Gemcitabine
Number: 0958
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses gemcitabine for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.
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Criteria for Initial Approval
Aetna considers gemcitabine (Avgemsi or generic gemcitabine) medically necessary for the treatment of the following indications:
- Ampullary adenocarcinoma;
- Kaposi sarcoma;
- B-cell lymphomas - including:
- Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma
- Mantle cell lymphoma
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphomas
- Burkitt lymphoma
- HIV-related B-cell lymphomas
- Post-transplant lymphoproliferative disorders;
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Bladder cancer - including:
- Primary carcinoma of the urethra
- Upper genitourinary tract tumors
- Transitional cell carcinoma of the urinary tract
- Urothelial carcinoma of the prostate
- Non-urothelial and urothelial cancer with subtype histology;
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Bone Cancer
- Ewing's sarcoma - relapsed, progressive, or metastatic disease
- Osteosarcoma - relapsed, refractory, or metastatic disease;
- Breast cancer - for treatment of members with no response to preoperative systemic therapy, recurrent, or metastatic disease;
- Cervical cancer;
- Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer - for treatment of advanced, persistent, or recurrent:
- Epithelial ovarian cancer
- Fallopian tube cancer
- Primary peritoneal cancer
- Carcinosarcoma (malignant mixed Mullerian tumors)
- Clear cell carcinoma of the ovary
- Grade 1 endometrioid carcinoma
- Low-grade serous carcinoma/ovarian borderline epithelial tumors (low malignant potential)
- Mucinous carcinoma of the ovary
- Malignant germ cell tumor;
- Gestational trophoblastic neoplasia;
- Head and neck cancer - including:
- Very advanced head and neck cancer
- Cancer of the nasopharynx
- Occult primary;
- Salivary gland tumors;
- Biliary tract cancer - including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer;
- Hodgkin Lymphoma - including:
- Classic Hodgkin lymphoma and pediatric Hodgkin lymphoma
- Nodular lymphocyte-predominant Hodgkin lymphoma - progressive, relapsed, or refractory disease;
- Kidney cancer - relapsed or metastatic disease;
- Malignant germ cell tumor;
- Pleural or peritoneal mesothelioma - including pericardial mesothelioma and tunica vaginalis testis mesothelioma;
- Non-small cell lung cancer (NSCLC);
- Occult primary tumors (cancer of unknown primary);
- Pancreatic adenocarcinoma;
- Primary cutaneous lymphomas (including mycosis fungoides/Sezary syndrome and primary cutaneous CD30+ T-cell lymphoproliferative disorders);
- Small cell lung cancer (SCLC);
- Soft tissue sarcoma - including angiosarcoma, extremity/body wall, head/neck, retroperitoneal/intra-abdominal, rhabdomyosarcoma, solitary fibrous tumor, dedifferentiated chordoma, dedifferentiated liposarcoma with or without concurrent well-differentiated liposarcoma, epithelioid hemangioendothelioma, and dermatofibrosarcoma protuberans (DFSP) with fibrosarcomatous transformation);
- Small bowel adenocarcinoma;
- T-cell lymphomas - including:
- Peripheral T-cell lymphomas
- Adult T-cell leukemia/lymphoma
- Hepatosplenic T-cell lymphoma
- Breast implant-associated anaplastic large cell lymphoma
- Extranodal NK/T-cell lymphoma;
- Testicular cancer;
- Thymomas and thymic carcinomas;
- Uterine neoplasms - including endometrial carcinoma, uterine sarcoma and uterine leiomyosarcoma;
- Vaginal cancer - for treatment of vaginal cancer when used as a single agent;
- Vulvar cancer - as concurrent chemoradiation as a single agent or in combination with cisplatin.
Aetna considers gemcitabine experimental, investigational, or unproven for all other indications.
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Continuation of Therapy
Aetna considers continuation of gemcitabine (Avgemsi or generic gemcitabine) therapy medically necessary for an indication listed in Section I when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Dosage and Administration
Gemcitabine is available as Avgemsi 200 mg/5.26 mL, 1 g/26.3 mL, and 2 g/52.6 mL (38 mg/mL) in a multiple-dose vial for intravnous infusion only.
The recommended dosing is as follows:
Ovarian Cancer
Administer 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
Breast Cancer
Administer 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
Non-Small Cell Lung Cancer
Administer 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
Pancreatic Cancer
Administer 1000 mg/m2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle.
Source: Avyxa Pharma, 2025; Meitheal Pharmaceuticals, 2024
Note: Gemcitabine is also available as a generic formulation. The branded products, Gemzar and Infugem have been discontinued by the manufacturer.
Background
U.S. Food and Drug Administration (FDA)-Approved Indications
- Ovarian cancer - In combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
- Breast cancer - In combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
- Non-small cell lung cancer - In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
- Pancreatic cancer - As first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.
Compendial Uses
- Ampullary adenocarcinoma
- Bladder cancer, primary carcinoma of the urethra, upper genitourinary tract tumors, transitional cell carcinoma of the urinary tract, urothelial carcinoma of the prostate, non-urothelial and urothelial cancer with subtype histology
- Bone cancer
- Ewing sarcoma
- Osteosarcoma
- Breast cancer
- Cervical cancer
- Head and neck cancers (including very advanced head and neck cancer, cancer of the nasopharynx, occult primary and salivary gland tumors)
- Biliary tract cancer
- Extrahepatic cholangiocarcinoma
- Intrahepatic cholangiocarcinoma
- Gallbladder cancer
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Hodgkin lymphoma
- Classic Hodgkin lymphoma
- Nodular lymphocyte-predominant Hodgkin lymphoma
- Kidney cancer
- Pleural or peritoneal mesothelioma
- Non-small cell lung cancer (NSCLC)
- Occult primary tumors (cancer of unknown primary)
- Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
- Pancreatic adenocarcinoma
- Small cell lung cancer (SCLC)
- Soft tissue sarcoma
- Testicular cancer
- Thymomas and thymic carcinomas
- Uterine neoplasms (including endometrial carcinoma, uterine sarcoma and uterine leiomyosarcoma)
- Kaposi Sarcoma
- Primary cutaneous lymphomas
- Mycosis fungoides/Sezary syndrome
- Primary cutaneous CD30+ T-Cell lymphoproliferative disorders
-
T-Cell lymphomas
- Peripheral T-Cell lymphomas
- Adult T-Cell leukemia/lymphoma
- Breast implant-associated anaplastic large cell lymphoma
- Extranodal natural killer (NK)/T-Cell lymphoma
- Hepatosplenic T-Cell lymphoma
- Gestational trophoblastic neoplasia
- B-Cell lymphomas
- Histologic transformation of indolent lymphomas to diffuse large B-Cell lymphoma
- Mantle cell lymphoma
- Diffuse large B-Cell lymphoma
- High-Grade B-Cell lymphomas
- Burkitt lymphoma
- Human immunodeficiency virus (HIV)-Related B-Cell lymphomas
- Post-Transplant lymphoproliferative disorders
- Small bowel adenocarcinoma
- Malignant germ cell tumor
- Vaginal cancer
- Vulvar cancer
Gemcitabine is available as Avgemsi (Avyxa Pharma, LLC.) and generic gemcitabine and is a nucleoside metabolic inhibitor that kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (self-potentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death (Avyxa Pharma, 2025).
The FDA has approved gemcitabine for the following indications:
- in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
- in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
- in combination with cisplatin, for the treatment of non-small cell lung cancer
- as a single agent for the treatment of pancreatic cancer.
On June 27, 2025, the FDA granted approval to gemcitabine (Avgemsi) solution for injection through the 505(b)(2) pathway for the following indications (FDA, 2025):
- Advanced ovarian cancer: in combination with carboplatin for the treatment of advanced ovarian cancer that has recurred at least six months following the completion of platinum-based therapy;
- Metastatic breast cancer: in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated;
- Non-small cell lung cancer (NSCLC): in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC);
- Pancreatic adenocarcinoma: as first-line treatment for patients diagnosed with locally advanced (non-resectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Avgemsi is indicated for patients previously treated with fluorouracil.
Breast Cancer
The efficacy of gemcitabine was evaluated in a multinational, randomized, open-label trial (Study 2) conducted in women receiving initial treatment for metastatic breast cancer and who have received prior adjuvant/neoadjuvant anthracycline chemotherapy unless clinically contraindicated. Patients were randomized to receive either gemcitabine 1250 mg/m2 on Days 1 and 8 of each 21-day cycle with paclitaxel 175 mg/m2 administered on Day 1 before gemcitabine administration (n=267) or paclitaxel 175 mg/m2 on Day 1 of each 21-day cycle (n=262). The major efficacy outcome measure was time to documented disease progression. A total of 529 patients were enrolled. Demographic and baseline characteristics were similar between treatment arms. The addition of gemcitabine to paclitaxel resulted in statistically significant improvement in median time to documented disease progression (5.2 months in the gemcitabine/paclitaxel group compared with 2.9 months in the paclitaxel group; p < 0.0001) and overall response rate (40.8% in the gemcitabine/paclitaxel group compared with 22.1% in the paclitaxel group; p < 0.0001) compared to paclitaxel alone. There was no significant difference in overall survival (18.6 months in the gemcitabine/paclitaxel group compared with 15.8 months in the paclitaxel group) (Eli Lilly 2019).
Non-Small Cell Lung Cancer
The efficacy of gemcitabine was evaluated in two randomized, multicenter trials (Eli Lilly 2019).
Study 3: 28-Day Schedule A multinational, randomized trial (Study 3) compared gemcitabine with cisplatin to cisplatin alone in the treatment of patients with inoperable Stage IIIA, IIIB, or IV NSCLC who had not received prior chemotherapy. Patients were randomized to receive either gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of each 28-day cycle with cisplatin 100 mg/m2 on Day 1 after gemcitabine administration (N=260) or cisplatin 100 mg/m2 on Day 1 of each 28-day cycle (N=262). The major efficacy outcome measure was overall survival. A total of 522 patients were enrolled. Demographics and baseline characteristics were similar between arms with the exception of histologic subtype of NSCLC, with 48% of patients on the cisplatin arm and 37% of patients on the gemcitabine with cisplatin arm having adenocarcinoma. The median survival was 9.0 months in the gemcitabine/cisplatin group compared with 7.6 months in the cisplatin group for Study 3; p = 0.008. The tumor response rate was 26% in the gemcitabine/cisplatin group compared with 10% in the cisplatin group for Study 3; p < 0.0001.
Study 4: 21-Day Schedule A randomized (1:1), multicenter trial (Study 4) was conducted in patients with Stage IIIB or IV NSCLC. Patients were randomized to receive either gemcitabine 1250 mg/m2 on Days 1 and 8 of each 21-day cycle with cisplatin 100 mg/m2 on Day 1 after gemcitabine administration or etoposide 100 mg/m2 intravenously on Days 1, 2, and 3 with cisplatin 100 mg/m2 on Day 1 of each 21 -day cycle. The major efficacy outcome measure was response rate. A total of 135 patients were enrolled. There was no significant difference in survival between the two treatment arms (8.7 months in the gemcitabine/cisplatin group compared with 7.0 months in the etoposide/cisplatin group for Study 4; p = 0.18). The median survival was 8.7 months for the gemcitabine with cisplatin arm versus 7 months for the etoposide with cisplatin arm. Median time to disease progression for the gemcitabine with cisplatin arm was 5 months compared to 4.1 months on the etoposide with cisplatin arm (Log rank p=0.015, two-sided). The objective response rate for the gemcitabine with cisplatin arm was 33% compared to 14% on the etoposide e with cisplatin arm (Fisher’s Exact p=0.01, two-sided). The tumor response rate was 33% in the gemcitabine/cisplatin group compared with 14% in the etoposide/cisplatin group for Study 4; p = 0.01.
Ovarian Cancer
The efficacy of gemcitabine was evaluated in a randomized trial (Study 1) conducted in women with advanced ovarian cancer that had relapsed at least 6 months after first-line platinum-based therapy. Patients were randomized to receive either gemcitabine 1000 mg/m2 on Days 1 and 8 of each 21-day cycle with carboplatin AUC 4 on Day 1 after gemcitabine administration (n=178) or carboplatin AUC 5 on Day 1 of each 21-day cycle (n=178). The major efficacy outcome measure was progression-free survival (PFS). A total of 356 patients were enrolled. The addition of gemcitabine to carboplatin resulted in statistically significant improvements in PFS (8.6 months in the gemcitabine/carboplatin group compared with 5.8 months in the carboplatin group; p = 0.0038) and overall response rate by investigator review (46.2% in the gemcitabine/carboplatin group compared with 30.9% in the carboplatin group; p = 0.0016). Approximately 75% of patients in each arm received additional chemotherapy for disease progression; 13 of 120 patients in the carboplatin alone arm received gemcitabine for treatment of disease progression. There was no significant difference in overall survival between the treatment arms (18 months in the gemcitabine/carboplatin group compared with 17.3 months in the carboplatin group; p = 0.8977) (Eli Lilly 2019).
Pancreatic Cancer
The efficacy of gemcitabine was evaluated in two trials (Studies 5 and 6), a randomized, single-blind, two-arm, active-controlled trial (Study 5) conducted in patients with locally advanced or metastatic pancreatic cancer who had received no prior chemotherapy and in a single-arm, open-label, multicenter trial (Study 6) conducted in patients with locally advanced or metastatic pancreatic cancer previously treated with fluorouracil or a fluorouracil-containing regimen. In Study 5, patients were randomized to receive either gemcitabine 1000 mg/m2 intravenously over 30 minutes once weekly for 7 weeks followed by a one-week rest, then once weekly for 3 consecutive weeks every 28-days in subsequent cycles (n=63) or fluorouracil 600 mg/m2 intravenously over 30 minutes once weekly (n=63). In Study 6, all patients received gemcitabine 1000 mg/m2 intravenously over 30 minutes once weekly for 7 weeks followed by a one-week rest, then once weekly for 3 consecutive weeks every 28-days in subsequent cycles. The major efficacy outcome measure in both trials was “clinical benefit response”. A patient was considered to have had a clinical benefit response if either of the following occurred: The patient achieved a ≥50% reduction in pain intensity (Memorial Pain Assessment Card) or analgesic consumption, or a 20-point or greater improvement in performance status (Karnofsky Performance Status) for a period of at least 4 consecutive weeks, without showing any sustained worsening in any of the other parameters. Sustained worsening was defined as 4 consecutive weeks with either any increase in pain intensity or analgesic consumption or a 20-point decrease in performance status occurring during the first 12 weeks of therapy. OR the patient was stable on all of the aforementioned parameters and showed a marked, sustained weight gain (≥7% increase maintained for ≥4 weeks) not due to fluid accumulation. Study 5 enrolled 126 patients. Demographics and baseline characteristics were similar between the arms. Patients treated with gemcitabine had statistically significant increases in clinical benefit response, survival, and time to disease progression compared to those randomized to receive fluorouracil. No confirmed objective tumor responses were observed in either treatment arm (Eli Lilly 2019).
Eshmuminov et al (2023) stated that pancreatic cancer often presents as locally advanced (LAPC) or borderline resectable (BRPC); neoadjuvant systemic therapy is recommended as initial treatment. Presently, it is unclear what chemotherapy should be preferred for patients with BRPC or LAPC. These investigators carried out a systematic review and meta-analysis of patient-level data regarding the use of initial systemic therapy for BRPC and LAPC. Outcomes were reported separately for tumor entity and by chemotherapy regimen including FOLFIRINOX (FIO) or gemcitabine-based. A total of 23 studies comprising 2,930 patients were analyzed for overall survival (OS) calculated from the beginning of systemic treatment. OS for patients with BRPC was 22.0 months with FIO, 16.9 months with gemcitabine/nab-paclitaxel (Gem/nab), 21.6 months with gemcitabine/cisplatin or oxaliplatin or docetaxel or capecitabine (GemX), and 10 months with gemcitabine monotherapy (Gem-mono) (p < 0.0001). In patients with LAPC, OS also was higher with FIO (17.1 months) compared with Gem/nab (12.5 months), GemX (12.3 months), and Gem-mono (9.4 months; p < 0.0001). This difference was driven by the patients who did not undergo surgery, where FIO was superior to other regimens. The resection rates for patients with BRPC were 0.55 for gemcitabine-based chemotherapy and 0.53 with FIO. In patients with LAPC, resection rates were 0.19 with gemcitabine and 0.28 with FIO. In resected patients, OS for patients with BRPC was 32.9 months with FIO and not different compared to Gem/nab, (28.6 months, p = 0.285), GemX (38.8 months, p = 0.1), or Gem-mono (23.1 months, p = 0.083). A similar trend was observed in resected patients converted from LAPC. The authors concluded that in patients with BRPC or LAPC, primary treatment with FOLFIRINOX compared with gemcitabine-based chemotherapy appeared to provide a survival benefit for patients who were ultimately unresectable. For patients who underwent surgical resection, outcomes were similar between GEM+ and FOLFIRINOX when delivered in the neoadjuvant setting.
Gemcitabine with Pazopanib or Gemcitabine with Docetaxel for the Treatment of Soft-Tissue Sarcoma
Somaiah et al (2021) noted that therapeutic options for patients with advanced soft-tissue sarcoma (STS) are limited. In an open-label, randomized, multi-center, phase- II clinical trial, these researchers examined the safety and effectiveness of combined gemcitabine plus pazopanib, a multi-tyrosine kinase inhibitor (TKI) with activity in STS. This trial enrolled patients with advanced non-adipocytic STS who had received prior anthracycline-based therapy. Subjects were assigned 1:1 to receive gemcitabine at a dose of 1,000 mg/m2 on days 1 and 8 with pazopanib at a dose of 800 mg daily (G+P) or gemcitabine at a dose of 900 mg/m2 on days 1 and 8 and docetaxel at a dose of 100 mg/m2 on day 8 (G+T) every 3 weeks. Cross-over was allowed at the time of disease progression. This trial employed a non-comparative statistical design based on the precision of 95 % confidence intervals (CIs) for reporting the primary endpoints of median PFS and rate of grade 3 or worse adverse events (AEs) for these 2 regimens based on the intent-to-treat (ITT) patient population (AEs were graded using version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events). A total of 90 patients were enrolled: 45 patients on each treatment arm. The median PFS was 4.1 months for each arm (p = 0.3, log-rank test). The best overall response of stable disease (SD) or better (complete response [CR] + partial response [PR] + SD) was the same for both treatment arms (64 % for both the G+T and G+P arms). The rate of related grade 3 or worse AEs was 82 % for the G+T arm and 78 % for the G+P arm. Related grade 3 or worse AEs occurring in 10 % or more of patients in the G+T and G+P arms were anemia (36 % and 20 %, respectively), fatigue (29 % and 13 %, respectively), thrombocytopenia (53 % and 49 %, respectively), neutropenia (20 % and 49 %, respectively), lymphopenia (13 % and 11 %, respectively), and hypertension (2 % and 20 %, respectively). The authors concluded that the findings of this trial suggested the similarity of the G+P regimen compared with G+T with regard to effectiveness and tolerability. In patients who are unsuitable for treatment with G+T (because of a contraindication or intolerance to docetaxel), G+P would be a reasonable alternate regimen for the 2nd-line treatment of those with metastatic non-adipocytic sarcomas.
Nivolumab, Gemcitabine, and Cisplatin or Nivolumab and Ipilimumab in Previously Untreated Advanced Biliary Cancer
Sahai et al (2022) stated that gemcitabine and cisplatin has limited benefit as treatment for advanced biliary tract cancer (BTC). The addition of an anti-programmed death receptor (PD-1)/PD-ligand (L1) antibody to either systemic chemotherapy or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibody has shown benefit in multiple solid tumors. In a phase-II clinical trial, patients 18 years of age or older with advanced BTC without prior systemic therapy and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 1 were randomized across 6 academic centers. Patients in Arm A received nivolumab (360 mg) on day 1 along with gemcitabine and cisplatin on days 1 and 8 every 3 weeks for 6 months followed by nivolumab (240 mg) every 2 weeks. Patients in Arm B received nivolumab (240 mg) every 2 weeks and ipilimumab (1 mg/kg) every 6 weeks. Of 75 randomized patients, 68 received therapy (Arm A = 35, Arm B = 33); 51.5 % women with a median age of 62.5 years. The observed primary outcome of 6-month PFS rates in the evaluable population was 59.4 % in Arm A and 21.2 % in Arm B. The median PFS and OS in Arm A were 6.6 and 10.6 months, and in Arm B 3.9 and 8.2 months, respectively, in patients who received any treatment. The most common treatment-related grade-3 or higher hematologic AE was neutropenia in 34.3 % (Arm A) and non-hematologic AEs were fatigue (8.6 % Arm A) and elevated transaminases (9.1 % Arm B). The authors concluded that the addition of nivolumab to chemotherapy or ipilimumab did not improve 6-month PFS. Although median OS was less than 12 months in both arms, the high OS rate at 2 years in Arm A suggested benefit in a small cohort of patients.
References
The above policy is based on the following references:
- Avyxa Pharma, LLC. Avgemsi (gemcitabine) injection, for intravenous use. Prescribing Information. Switzerland; Avyxa Pharma; revised July 2025.
- Clinical Pharmacology. Gemcitabine. Clinical Pharmacology powered by Clinical Key. Philadelphia, PA: Elsevier; 2023. Available at: https://www.clinicalkey.com/pharmacology/. Accessed July 1, 2024.
- Eli Lilly and Company. Gemzar (gemcitabine) for injection, for intravenous use. Prescribing Information. Indianapolis, IN: Eli Lilly; revised May 2019.
- Elsevier Inc. Clinical Pharmacology powered by ClinicalKey. Tampa, FL: Elsevier; updated periodically.
- Eshmuminov D, Aminjonov B, Palm RF, et al. FOLFIRINOX or gemcitabine-based chemotherapy for borderline resectable and locally advanced pancreatic cancer: A multi-institutional, patient-level, meta-analysis and systematic review. Ann Surg Oncol. 2023;30(7):4417-4428.
- Lexicomp. Gemcitabine. Lexi-Drugs. Lexicomp Online. Hudson, OH: Lexicomp; 2023. Avaiable at: https://online.lexi.com. Accessed July 1, 2024.
- Meitheal Pharmaceuticals Inc. Gemcitabine for injection, for intravenous use. Prescribing Information. Chicago, IL: Meitheal Pharmaceuticals; October 2024.
- Merative L.P. In-Depth Answers. Merative Micromedex. Ann Arbor, MI: Merative; updated periodically.
- National Comprehensive Cancer Network (NCCN). Gemcitabine. NCCN Drugs & Biologics Compendium. Plymouth Meeting, PA: NCCN; July 2025.
- National Comprehensive Cancer Network (NCCN). Gestational trophoblastic neoplasia. NCCN Clinical Practice Guidelines in Oncology, Version 1.2023. Plymouth Meeting, PA: NCCN; December 2022.
- Sahai V, Griffith KA, Beg MS, et al. A randomized phase 2 trial of nivolumab, gemcitabine, and cisplatin or nivolumab and ipilimumab in previously untreated advanced biliary cancer: BilT-01. Cancer. 2022;128(19):3523-3530.
- Somaiah N, Van Tine BA, Wahlquist AE, et al. A randomized, open-label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft-tissue sarcoma. Cancer. 2021;127(6):894-904.
- Sun Pharmaceutical Industries, Inc. Infugem (gemcitabine in sodium chloride injection), for intravenous use. Prescribing Information. Cranbury, NJ: Sun Pharmaceutical Industries; revised January 2020.
- Sun Pharmaceutical Industries, Inc. Sun Pharma announces U.S. FDA approval of Infugem injection. Press Release. Cranbury, NJ: Sun Pharmaceutical Industries; July 18, 2018.
- U.S. Food and Drug Adminstration (FDA). Approval letter for [Avgemsi (gemcitabine) injection] (NDA 219920). Silver Spring, MD: FDA; June 27, 2025.
- UpToDate Inc. UpToDate Lexidrug [online]. Waltham, MA: UpToDate; updated periodically.
