Pfizer PFE and its German partner Merck KGaA announced that the FDA has approved their supplemental Biologics License Application (sBLA) for PD-L1 inhibitor, Bavencio (avelumab). The sBLA was looking to get the label for Bavencio expanded for the first-line treatment for advanced renal cell carcinoma (“RCC”), the most common form of kidney cancer, in combination with Pfizer’s another cancer drug, Inlyta (axitinib).
Please note that the decision came earlier than expected. It was originally expected in June. We remind investors that a similar label expansion regulatory application is under review in Europe. It was validated for review by the European Medicines Agency in March.
Bavencio is presently approved for the treatment of metastatic Merkel cell carcinoma and metastatic urothelial carcinoma in patients whose disease progressed following chemotherapy while Inlyta is approved for second-line treatment of advanced RCC.
Pfizer’s stock has declined 6.9% so far this year compared with the industry’s decrease of 2.7%.
The approval was based on data from the phase III JAVELIN Renal 101 study, which evaluated the Bavencio/Inlyta combination against Pfizer’s older kidney cancer drug, Sutent. Data from the study, presented in the past, showed that the combination regimen led to statistically significant improvement in progression-free survival in patients whose tumors had PD-L1 expression greater than 1% as well as in the entire study population regardless of PD-L1 tumor expression. The study is currently evaluating the regimen for improvement in overall survival.
While the RCC market holds immense potential, competition is stiff. Last month, the sBLA seeking approval for Merck’s MRK Keytruda in combination with Inlyta for the first-line treatment of patients with advanced RCC was approved by the FDA. Bristol-Myers’ BMY Opdivo and Yervoy for the treatment of poor and intermediate risk first-line RCC was also approved in the same month. Meanwhile, Exelixis’ EXEL Cabometyx is a dominant player in the market.
Currently, Bavencio is being developed for more than 15 types of tumors, including breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, melanoma, mesothelioma, Merkel cell carcinoma, non-small cell lung cancer, ovarian and urothelial carcinoma. These studies are part of the JAVELIN development program.
However, the drug failed in three ovarian cancer studies in the past year including the phase III JAVELIN Ovarian PARP 100 study evaluating Bavencio with Pfizer’s PARP inhibitor, Talzenna (talazoparib), which was discontinued in March this year.
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Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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