FDA Accepts Supplemental Biologics License Application For KEYTRUDA

FDA Accepts Supplemental Biologics License Application For KEYTRUDA

Merck recently announced that the U.S. Food and Drug Administration (FDA) has agreed to review a supplemental Biologics License Application (sBLA) for the company’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), with the goal of treating patients suffering with advanced non-small cell lung cancer (NSCLC). In particular, Merck believes that KEYTRUDA can be prescribed in cases where the disease has progressed on or after the use of platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations. Pursuant to this announcement, the FDA also granted Priority Review with a PDUFA date of October 2, 2015; the sBLA will be reviewed under the FDA’s Accelerated Approval program.

Pembrolizumab targets programmed cell death 1 (PD-1) receptors, activating the immune system to fight tumors. This drug has anti-tumor activity in patients with NSCLS.

“Today’s announcement reflects our commitment to accelerate the development of immunotherapeutic approaches to treat lung cancer, one of the most deadly malignancies. We believe that data submitted to the FDA illustrate the significant potential of KEYTRUDA to treat advanced non-small cell lung cancer — and we look forward to working with the FDA to bring our anti-PD-1 therapy to patients afflicted with this devastating cancer,” said Roger M. Perlmutte, president of Merck Research Laboratories.

The sBLA submission was supported through data from KEYNOTE-001, which included patients with more or equal value of 50 percent of PD-L1 expression in tumor cells. The positive data also supported the FDA Breakthrough Therapy designation for KEYTRUDA for the treatment of advanced NSCLC. Merck submitted the documents for the approval of KEYTRUDA monotherapy to be administered at a dose of 2 mg/kg each 3 weeks; this is the currently approved dose to address advanced melanoma.

As it was already announced, a Pre-market Approval Application (PMA) was submitted for an immunohistochemistry companion diagnostic test that detects PD-L1 expression, PD-L1 IHC 22C3 PharmDx™ by Agilent Technologies Company and Dako North America, Inc.

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A Phase II clinical trial supervised by Joshua Bauml of Penn’s Abramson Cancer Center will assess whether Pembrolizumab can improve survival in non-small cell lung cancer (NSCLC) patients. The trial will enroll 42 patients who have completed conventional treatments (surgery, chemotherapy, radiation and other ablative therapies) and have no signs of cancer.

The trial, funded by Merck, is designed for patients with oligometastatic lung cancer — a state characterized by a limited number of metastases in a confined area. The survival for these patients is 20 months, while overall survival for patients with metastatic disease is six to 12 months.

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