Oncology

FDA Approves Koselugo for Treatment of Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved the kinase inhibitor KOSELUGO™ (selumetinib) for the treatment of pediatric patients two years of age and older with …

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Study Shows Guardant360 Test Identifies Predictors of Response to PIK3CA Inhibitors in Women with HR+ Metastatic Breast Cancer

REDWOOD CITY, Calif., April 09, 2020 (GLOBE NEWSWIRE) — Many women with metastatic hormone receptor-positive (HR+) breast cancer have experienced improved clinical outcomes with the recent introduction of alpelisib, a PIK3CA inhibitor. A new study led by Memorial Sloan Kettering Cancer Center and published in Nature Cancer1 demonstrates that the Guardant360® liquid biopsy test effectively …

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FDA Grants Breakthrough Therapy Designation to Bavencio for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Rockland, MA and New York, US, April 9, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration …

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FDA Approves Pfizer’s Braftovi Plus Cetuximab for Previously Treated Metastatic CRC Patients with a BRAF-V600 Mutation

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.1 The approval is …

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Agenus Receives FDA Fast Track Designation for Balstilimab in Advanced Cervical Cancer

LEXINGTON, Mass., April 7, 2020 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of …

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FDA Grants Priority Review to Merck’s Application for Keytruda Based on Biomarker, Regardless of Tumor Type

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA …

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FDA Grants Fast Track Designation to Blaze’s BLZ-100 for Pediatric Central Nervous System Tumors

SEATTLE–(BUSINESS WIRE)–Blaze Bioscience, Inc., the Tumor Paint Company®, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, announced today that its clinical program evaluating tozuleristide (BLZ-100) for pediatric brain tumors, has been granted Fast Track designation from the U.S. …

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FDA Approves AstraZeneca’s Imfinzi for Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that IMFINZI® (durvalumab) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide and either carboplatin or cisplatin (platinum-etoposide). The approval by the US Food and Drug Administration was …

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Pfizer and EMD Serono Terminate Phase 3 Study of Avelumab Plus CRT for Treatment of Head and Neck Cancer

ROCKLAND, Mass. and NEW YORK, March 13, 2020 /PRNewswire/ — EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy …

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FDA Grants Fast Track Designation to Balstilimab and Zalifrelimab for Treatment of Advanced Cervical Cancer

LEXINGTON, Mass., March 12, 2020 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination …

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