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Pfizer sBLA for Kidney Cancer Drug Combo Gets Priority Review

PfizerPFE and its partner Merck KGaA MKGAF announced that the supplemental Biologics License Application (sBLA) for Bavencio (avelumab), in combination with Pfizer's another cancer drug Inlyta (axitinib) was granted priority review by the FDA. The sBLA is seeking approval of the drug combination as a treatment for advanced renal cell carcinoma ("RCC"), the most common form of kidney cancer. The FDA's decision is expected in June 2019.

While Bavencio is approved for treatment of metastatic Merkel cell carcinoma and metastatic urothelial carcinoma in patients whose disease progressed following a chemotherapy, Inlyta is approved for second-line treatment of advanced RCC.

The sBLA was filed based on interim 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 ("PFS") 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 ongoing study is currently evaluating the regimen for improvement in overall survival ("OS").

We note that Pfizer is developing Bavencio in JAVELIN program, which consists of at least 30 clinical studies evaluating the drug in more than 15 different cancer indications. Although Bavencio is approved two small cancer indication, successful development in the ongoing studies will help its label to expand into major indications. The company considers Bavencio, an anti PD-L1 antibody, as a key driver of its long-term growth. It is mainly focusing on developing the drug in combination with its other targeted therapies. PD-1/PD-L1 targeted therapies hold tremendous potential as evident from the growth of Merck's MRK Keytruda and Bristol-Myers' BMY Opdivo, which are PD-1 inhibitors.

Pfizer's stock has risen 2.1% in the past six months, in line with the i ndustry 's increase in the same time frame.

In a separate press release, Pfizer announced that it will present data from the phase III ARCHES study evaluating Xtandi for treating metastatic hormone-sensitive prostate cancer (mHSPC). The company stated that the drug in combination with androgen deprivation therapy ("ADT") significantly reduced the risk of radiographic progression or death by 61% compared to ADT alone.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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