Oncology

FDA Grants Priority Review to Clovis Oncology’s Rubraca for Treatment of Advanced Prostate Cancer

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca® (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis …

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FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo Plus Yervoy in First-Line NSCLC

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. …

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FDA Accepts and Grants Priority Review to sNDA for Lynparza as First-Line Maintenance with Bevacizumab in Advanced Ovarian Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the maintenance treatment …

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Tyvyt Combined with Alimta and Platinum Met Predefined Primary Endpoint in Phase 3 Study as First-Line Therapy in Nonsquamous NSCLC

INDIANAPOLIS, Jan. 13, 2020 /PRNewswire/ — Today, Eli Lilly and Company (NYSE: LLY) jointly announced with Innovent Biologics, Inc. the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation …

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Incyte Pays $750 Million Upfront for Rights to MorphoSys’ Investigational Cancer Drug

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) and Incyte Corporation (NASDAQ: INCY) announced today that the companies have entered into a collaboration and license agreement to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab (MOR208) globally. Tafasitamab is an Fc-engineered antibody against CD19 currently …

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Concerto HealthAI and Pfizer Expand Collaboration to Accelerate Real-World Evidence and AI Technologies for Additional Disease Areas

BOSTON, Jan. 10, 2020 /PRNewswire/ — Concerto HealthAI announced an expansion of their existing Precision Oncology collaboration with Pfizer Oncology to advance Concerto HealthAI’s use-case engineered Real-World Data (RWD) for an array of clinical development initiatives across breast, lung, prostate and renal cell carcinoma cancers that will drive innovative new …

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FDA Approves Blueprint Medicines’ Ayvakit for Treatment of Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth …

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ADC Therapeutics Announces Positive Results from its Phase 2 Trial of Loncastuximab Tesirine in Relapsed or Refractory DLBCL

Lausanne, Switzerland, January 9, 2020 – ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, today announced positive results from the pivotal 145-patient Phase 2 clinical trial of loncastuximab tesirine (ADCT-402) …

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FDA Approves Keytruda for Certain Patients with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

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 approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in …

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Personal Genome Diagnostics and Mayo Clinic Enter Strategic Collaboration to Enhance Patient Care in Oncology

BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, today announced a strategic collaboration with Mayo Clinic to enhance the development of clinical diagnostic solutions for oncology. Together, PGDx and Mayo Clinic will focus on technology optimization and clinical utility studies for liquid biopsy and tissue-based genomic applications. The two organizations …

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