Merck said FDA has extended the action date for the supplemental Biologics License Application for Keytruda as monotherapy for the first-line treatment of locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations.
Merck said Keytruda (pembrolizumab), an anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency, including three expanded uses in advanced non-small lung cancer, one in melanoma, as well as a new indication in advanced microsatellite instability-high tumors. The following new approvals were all granted priority review by the PMDA:
The Ministry of Health, Labour and Welfare of Japan has approved FoundationOne CDx as a comprehensive genomic profiling test for all solid tumors and a broad companion diagnostic for individuals living with advanced cancer.
FDA approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses, compared to other available pegaspargase products.
Gritstone Oncology Inc. said FDA has granted Fast Track designation to GRANITE-001 for the treatment of colorectal cancer. GRANITE-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone's proprietary EDGETM artificial intelligence platform as the most relevant neoantigens to drive a tumor-specific T-cell attack.
Clovis Oncology Inc. said the European Union's European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending an additional indication to include rucaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
FDA has granted orphan drug designation to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer. The designation follows the recent presentation of the first clinical data for M7824 in BTC at the European Society of Medical Oncology congress in October.
FDA has approved Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
FDA has published a draft guidance on “class labeling” of diagnostic tests for oncology therapeutic products, where scientifically appropriate.
FDA has published a document outlining it approach to interpretation of real-world evidence.
