Oncology

FDA Approves Roche’s Ventana HER2 Dual ISH Test as a Companion Diagnostic to Identify Breast Cancer Patients Eligible for Targeted Therapy

Basel, 29 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. …

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FDA Grants Breakthrough Therapy Designation to Merck’s MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients …

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Spectrum Announces Positive Topline Results in HER2 Exon20 Insertion Mutations from Cohort 2 of the Poziotinib ZENITH20 Trial

HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that it met the pre-specified primary endpoint in the ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations …

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AstraZeneca to Pay Daiichi Sankyo Up to $6 Billion for its New Cancer Drug

AstraZeneca has entered into a new global development and commercialization agreement with Daiichi Sankyo Company, Limited (Daiichi Sankyo) for DS-1062, Daiichi Sankyo’s proprietary trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) and potential new medicine for the treatment of multiple tumor types. DS-1062 is currently in development for the …

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Puma Biotechnology Announces Publication of Results from Phase 2 Study Evaluating Neratinib in HER2-Mutant, Metastatic Cervical Cancers

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that data from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the safety and efficacy of neratinib in HER2-mutated cancers, were published in the journal Gynecologic Oncology. The paper, “Neratinib in patients with HER2-mutant, metastatic cervical cancer: …

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FDA Grants Fast Track Designation to Checkmate’s CMP-001 Combined with PD-1 Blockade for Treatment of Certain Types of Advanced Melanoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Checkmate Pharmaceuticals, Inc. (Checkmate), a clinical-stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its product candidate, CMP-001, a differentiated Toll-like receptor 9 …

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Lilly and Zentalis Collaborate to Evaluate the Combination of Abemaciclib with an Oral SERD Product Candidate in Advanced Breast Cancer

NEW YORK & SAN DIEGO, July 27, 2020 (GLOBE NEWSWIRE) — Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced a clinical collaboration agreement with Eli Lilly and Company (NYSE: LLY, “Lilly”) in which …

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FDA Approves Kite’s Tecartus, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or …

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Phase 3 Trial of Incyte’s Jakafi Met Primary and Both Secondary Endpoints in Patients with Chronic Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that the Phase 3 REACH3 study evaluating ruxolitinib (Jakafi®) in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD) met its primary endpoint of superior overall response rate (ORR) at Week 24 compared to best available therapy (BAT). In addition, …

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BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities

FRANKLIN LAKES, N.J., July 22, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity™ HPV …

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