What Is Bavencio (avelumab)? FDA Approval History and Status in Turkey
| Active ingredient | Avelumab |
| Brand name | Bavencio |
| Class | Human IgG1 monoclonal antibody, PD-L1 inhibitor |
| Category | Immune checkpoint inhibitor, immunotherapy |
| Administration | Intravenous (IV) infusion |
| Frequency | Every 14 days (every 2 weeks), fixed 800 mg dose |
| Approved cancers | Merkel cell carcinoma · Urothelial (bladder/urinary tract) carcinoma (1st-line maintenance) · Renal cell carcinoma (with axitinib, 1st line) |
| FDA approved | Yes — first approval March 23, 2017; four separate approval steps in total |
| EMA/European approval | Yes — since September 2017, for indications following the FDA approvals |
| Frequently combined drugs | Axitinib (Inlyta) — only in the renal cell carcinoma indication |
| Manufacturer | EMD Serono / Pfizer (global) — Merck İlaç (distribution in Turkey) |
| Republic of Turkey Ministry of Health license | YES — 18.08.2019 |
| SGK reimbursement | PARTIAL — only for urothelial carcinoma maintenance and Merkel cell carcinoma; the renal cell carcinoma (+axitinib) indication currently does not appear to be covered in verifiable sources (see Section 8) |
| Half-life | Approximately 6 days |
Avelumab, unlike other checkpoint inhibitors blocking the PD-L1/PD-1 pathway, combines both "releasing the brake" and directing immune cells straight toward the tumor (ADCC) in the same molecule. It is a PD-L1 inhibitor . Approved for Merkel cell carcinoma in 2017, it became the first immunotherapy for this rare cancer, later gaining a place in urothelial and renal cell carcinoma.
This monograph examines how the drug works; the clinical evidence underlying three separate FDA approvals— the survival benefit of maintenance therapy in JAVELIN Bladder 100 and the fact that overall survival did not reach statistical significance in the final JAVELIN Renal 101 analysis —and the current licensing, reimbursement, and pricing situation in Turkey.
PD-L1 is a molecule on the surface of tumor cells and some immune cells. It "silences" T cells by binding to their PD-1 receptor. Tumors exploit this mechanism to hide from the immune system.
Avelumab is a human IgG1 antibody that binds PD-L1 and blocks both PD-L1–PD-1 and PD-L1–B7.1 interactions, reactivating the T-cell immune response and enabling T-cell activation and proliferation. Unlike other PD-L1/PD-1 checkpoint antibodies, its IgG1 structure also allows it to trigger antibody-dependent cellular cytotoxicity (ADCC) —directing immune cells straight toward the marked tumor cell.
| Date | Approval | Evidence |
|---|---|---|
| March 23, 2017 | Metastatic Merkel cell carcinoma —the first FDA-approved treatment for this rare and aggressive skin cancer. | JAVELIN Merkel 200 |
| May 9, 2017 | Locally advanced or metastatic disease progressing during/after platinum-based chemotherapy or within 12 months of adjuvant/neoadjuvant platinum treatment: urothelial carcinoma. | Accelerated approval |
| May 14, 2019 | In combination with axitinib, for first-line treatment of advanced renal cell carcinoma . | JAVELIN Renal 101 |
| June 30, 2020 | Maintenance treatment of locally advanced or metastatic urothelial carcinoma in patients without progression after first-line platinum-based chemotherapy. | JAVELIN Bladder 100 |
JAVELIN Merkel 200 studied avelumab in a single arm of 88 patients with metastatic Merkel cell carcinoma that had progressed after chemotherapy. At two-year follow-up, the objective response rate was 33% (95% CI 23.3-43.8), and the complete response rate was 11.4% . Among responders, responses were ongoing in 19/29, and response duration exceeded 2 years in 12 patients, supporting the durable response pattern characteristic of immunotherapy.
- This is a single-arm phase 2 study —there is no comparator arm. The accelerated approval in 2017 reflected the absence of any approved treatment for this disease at that time.
- 2-year overall survival was 36% —although outcomes were much better in the subgroup with durable responses, the disease still has a serious prognosis in the overall population.
In patients with urothelial carcinoma without progression after platinum-based chemotherapy, avelumab maintenance plus best supportive care was compared with best supportive care alone. In the initial analysis (October 2019 cutoff), median overall survival was 21.4 versus 14.3 months (HR 0.69).
The difference was maintained in the update with longer follow-up (June 2021 cutoff): median overall survival was 23.8 versus 15.0 months (HR 0.76); 3-year survival was 49.8% versus 38.4%. Progression-free survival was 5.5 versus 2.1 months.
Only 11.4% of patients in the control arm subsequently received a PD-1/PD-L1 inhibitor; this proportion was much lower in the avelumab arm, where patients were already receiving treatment. In the control arm, 53% moved to another treatment in later lines. This supports the possibility that starting maintenance treatment early may itself contribute benefit—but differences in subsequent therapies should also be considered when interpreting the comparison.
In advanced renal cell carcinoma, JAVELIN Renal 101 compared avelumab + axitinib with sunitinib as first-line treatment. The study met its prespecified primary endpoint of progression-free survival (PFS) , which supported the FDA approval in 2019.
However, the final analysis with an August 2023 data cutoff and median follow-up of 73.7 months presents a different picture for overall survival (OS): avelumab + axitinib was numerically better than sunitinib, but did not reach statistical significance. In the PD-L1-positive subgroup, median overall survival was 43.2 versus 36.2 months .
- The PFS benefit is the actual, official basis for FDA approval —there is no uncertainty about that.
- However, the final overall survival analysis after ~6 years (73.7 months) of follow-up did not reach statistical significance. A numerical trend favoring avelumab + axitinib was reported, but this does not mean "proven survival superiority."
- Conclusion: JAVELIN Renal 101 is positive for progression-free survival, not final overall survival. This distinction should be made clear in treatment discussions with patients and physicians, particularly when choosing between avelumab + axitinib and other first-line combinations, such as nivolumab + cabozantinib or pembrolizumab + axitinib.
Reported mechanisms include increased expression/activity of other immune checkpoint pathways (TIGIT, TIM3, LAG3); increases in other immune-evasion mechanisms; greater infiltration of immunosuppressive populations into the tumor microenvironment, such as Treg cells, myeloid-derived suppressor cells, and M2 macrophages ; and release in the tumor microenvironment of cytokines, chemokines, and metabolites such as CSF-1, tryptophan metabolites, TGF-β, and adenosine .
- Fatigue and asthenia —the most commonly reported general adverse effects.
- Infusion-related reactions —particular care is needed during the first 4 infusions.
- Gastrointestinal: Nausea, vomiting, decreased appetite; colitis with diarrhea and abdominal pain.
- Musculoskeletal: Arthralgia, oligoarthritis, polyarthritis, tenosynovitis, polymyalgia rheumatica, and myalgias.
- Endocrinopathies: Including hypophysitis, thyroid disorders, adrenal insufficiency, and diabetes.
- Neurological effects: Neuropathy, myositis; rarely myasthenia gravis, Guillain-Barré syndrome, or meningoencephalitis.
- Skin: Rash and itching.
- Respiratory: Dyspnea and cough.
- Liver: Hepatic adverse effects with increased AST, ALT, and serum bilirubin.
- Blood: Anemia, thrombocytopenia, lymphopenia, and neutropenia.
- Pancreas: Increased serum lipase and amylase.
- Immune-mediated adverse effects can affect any organ system. The most common include pneumonitis, hepatitis, colitis, hypophysitis, pancreatitis, neurological disorders, and adrenal and thyroid dysfunction.
- Premedication for infusion reactions: Before the first 4 infusions, patients should receive an antihistamine and acetaminophen as premedication. For mild/moderate reactions, the infusion is slowed or interrupted; for severe/life-threatening reactions, it is permanently discontinued.
- Endocrine monitoring: Before and during treatment, thyroid and adrenal function should be monitored regularly. Patients should also be monitored for signs of hyperglycemia and diabetes.
- Hepatic/renal impairment: No dose adjustment is needed in mild-to-moderate hepatic or renal impairment. Avelumab has not been studied in severe hepatic impairment.
- Pregnancy and fertility: Based on its mechanism of action, it may harm the fetus. Women of reproductive potential are advised to use effective contraception during treatment and for at least 1 month after the last dose . It should not be used during breastfeeding.
- Drug interactions: No well-characterized drug interaction has been reported to date.
Route: Intravenous (IV) infusion. For bladder cancer, Merkel cell carcinoma, and kidney cancer, the recommended dose is a fixed 800 mg every 14 days (not adjusted for body weight). Dose and schedule decisions belong solely to the treating oncology team; this monograph provides no dose-adjustment information.
Distribution: Mean volume of distribution in the body is 4.72 L; steady-state levels are reached in 4-6 weeks .
Metabolism and half-life: The main elimination pathway is proteolytic degradation. Terminal half-life is approximately 6 days.
License: Bavencio was licensed by the Republic of Turkey Ministry of Health on 18.08.2019 for three indications: metastatic Merkel cell carcinoma (monotherapy); maintenance after 1st-line platinum chemotherapy in PD-L1-positive urothelial carcinoma (monotherapy); and 1st-line combination with axitinib in PD-L1-positive clear-cell renal cancer.
Reimbursement: SGK covers urothelial carcinoma maintenance (monotherapy until progression, following at least 4 cycles of platinum chemotherapy, PD-L1-positive, without progression, started within 10 weeks of the last chemotherapy dose) and Merkel cell carcinoma (monotherapy until progression in patients progressing after chemotherapy).
For renal cell carcinoma (+axitinib): At the time of writing, no clear confirmation could be found in verifiable sources that SGK covers this combination. A license does not mean reimbursement. The current SUT/EK-4 list must be checked through pharmacy or SGK sources before prescribing; this can change over time.
As of August 2026, Bavencio 200 mg/10 ml, 1 vial, is listed at 24,428.41 ₺ . A standard 800 mg dose requires 4 vials , corresponding to approximately 97,713.64 ₺ per infusion in a regimen repeated every 14 days. These figures may be updated over time; pharmacies or drug price lists should be checked for current pricing.
Who is this drug for? There are three approved uses: metastatic Merkel cell carcinoma; maintenance in PD-L1-positive urothelial carcinoma; and first-line treatment with axitinib in PD-L1-positive clear-cell kidney cancer. Appropriate use in urothelial and kidney cancer requires PD-L1 testing to have been performed.
What can you expect? The survival benefit in urothelial carcinoma maintenance is well documented. In kidney cancer, delaying progression is proven, but a long-term survival extension has not yet been statistically demonstrated —a distinction worth remembering when speaking with your oncologist.
What should you watch for? Immune-mediated adverse effects can affect any organ . Report new cough/breathlessness, jaundice, diarrhea, excessive thirst/frequent urination, muscle or joint pain, or unusual fatigue to your oncology team. Reactions such as fever, chills, or itching during or after infusion should also be reported.
Avelumab's approvals in three cancers—Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma—demonstrate the broad applications of PD-L1 inhibition. Its ability to trigger ADCC through its IgG1 structure is a mechanistic distinction from other members of the class, but whether this adds a tangible clinical benefit remains unclear.
JAVELIN Merkel 200: Single-arm; ORR 33%, complete response 11.4%, with most responses durable. JAVELIN Bladder 100: Strong OS benefit in maintenance—HR 0.69 initially and HR 0.76 with longer follow-up; 3-year survival 49.8% vs 38.4%. JAVELIN Renal 101: PFS benefit is the official basis for FDA approval; in the final analysis with ~74 months of follow-up, OS numerically favored the combination but did not reach statistical significance (43.2 vs 36.2 months in the PD-L1+ subgroup).
Merkel cell carcinoma evidence is single-arm and noncomparative —with a small population (n=88), the exact effect size remains uncertain. In kidney cancer, final OS did not reach significance, making the position of axitinib combination therapy debatable compared with other first-line options, such as nivolumab+cabozantinib and pembrolizumab+axitinib, with more clearly demonstrated OS superiority. Part of the survival difference in urothelial maintenance may reflect the low subsequent-treatment rate in the control arm. An important limitation specific to Turkey is that SGK reimbursement for the kidney cancer indication could not be confirmed.
Every patient with urothelial carcinoma responding to platinum chemotherapy without progression should be assessed for avelumab maintenance—the indication with the strongest demonstrated PFS/OS benefit. When selecting first-line kidney cancer therapy, the difference in OS evidence between avelumab + axitinib and other combinations should be discussed with the patient. PD-L1 testing is a prerequisite for treatment decisions in urothelial and kidney cancer. Before prescribing for kidney cancer in Turkey, current reimbursement status should be checked through SGK/SUT sources.
Whether ADCC, compared with other antibodies providing pure PD-1/PD-L1 blockade, offers a real clinical advantage remains open. Why OS did not reach significance in kidney cancer—crossover, subsequent treatments, or a true efficacy difference—remains unclear. Will a randomized comparative study be conducted in Merkel cell carcinoma? And the practical question for Turkey: when will SGK reimbursement for the kidney cancer indication become clear?
- This document contains no dosing information and recommends no treatment regimen.
- The final JAVELIN Renal 101 OS analysis is not statistically significant —this should not be confused with the PFS benefit.
- JAVELIN Merkel 200 is a single-arm study without a randomized comparison.
- SGK reimbursement for the renal cell carcinoma indication could not be confirmed for this article —current sources should be consulted for the latest status.
- Price information is time-dependent and may have changed.
- Applicable only to patients with confirmed relevant PD-L1 status in the urothelial and kidney cancer indications.
- The decision to use it belongs solely to the medical oncologist who knows the patient.
- Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17(10):1374-1385.
- Kaufman HL, et al. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018;6(1):7.
- Powles T, Park SH, Voog E, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020;383(13):1218-1230.
- Powles T, et al. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up. J Clin Oncol. 2023;41(19):3486-3492.
- Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1103-1115.
- Avelumab + axitinib versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma: final analysis of the phase III JAVELIN Renal 101 trial. Ann Oncol. 2024.
- U.S. Food and Drug Administration. Approval announcements (March 23, 2017 · May 9, 2017 · May 14, 2019 · June 30, 2020).
- Republic of Turkey Ministry of Health—Bavencio (avelumab) license record, 18.08.2019.
- Social Security Institution—Health Implementation Communiqué (SUT), relevant annex lists.
- NCCN Clinical Practice Guidelines in Oncology—Bladder Cancer, Kidney Cancer, Merkel Cell Carcinoma, 2026 versions.
- Related reading (drozdogan.com): Maintenance treatment approval for bladder/ureter cancer · Stage 4 kidney cancer: 1st-line treatment · 3 new immunotherapy approvals for bladder and urinary tract cancer · First drug approval for Merkel cell skin cancer · What is PD-L1, and what does its test mean? · Immunotherapies and cancer vaccines · How are immunotherapy side effects treated?.
Editor's note: This monograph is for general information only; it is not medical advice, a diagnosis, or a treatment recommendation and does not promote any product. All reported data have been verified against primary sources and presented without direct quotation. Drug doses, detailed schedules, and dose-adjustment information are deliberately not included in this document; these are solely the responsibility of the treating physician. Bavencio (avelumab) is licensed in Turkey by the Republic of Turkey Ministry of Health (18.08.2019) and covered by SGK for urothelial carcinoma maintenance and Merkel cell carcinoma; reimbursement for renal cell carcinoma (+axitinib) could not be confirmed from verifiable sources at the time of writing and should be checked against current SUT/EK-4 lists before prescribing. The stated price (as of August 2026) may change over time and is for information only. The final JAVELIN Renal 101 overall survival analysis did not reach statistical significance; this should not be confused with the progression-free survival benefit. Treatment selection depends not only on these data but also on the patient's general condition, comorbidities, and preferences. JAVELIN Merkel 200 is a single-arm study and does not provide randomized comparative evidence. This drug is relevant only to patients in the appropriate indications and, for urothelial/kidney cancer, with confirmed PD-L1 status . Do not stop or change any medication without consulting your physician. For drug access and reimbursement, consult only your treating medical oncologist and current SGK announcements. For every decision about your health, consult the physician who knows you.
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