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Oncology

Gamida Cell and Editas Medicine Partner to Evaluate Use of CRISPR Genome Editing Technology in NAM-NK Cells

BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, today announced an agreement with Editas Medicine, Inc., a leading genome editing company, to evaluate the potential use of Editas Medicine’s CRISPR technology to edit NAM-NK cells, which are natural killer cells that have been expanded using Gamida …

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FDA Approves Merck’s Keytruda for the Adjuvant Treatment of Melanoma Patients with Lymph Node Involvement Following Complete Resection

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, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from …

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Genentech’s Polatuzumab Vedotin Granted Priority Review from the FDA for Previously Treated Aggressive Lymphoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan®(rituximab) (BR) for the …

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Alkermes and Clovis Oncology Enter Research Collaboration to Explore Combination Cancer Therapies

DUBLIN and BOULDER, Colo., Feb. 19, 2019 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) and Clovis Oncology, Inc. (Nasdaq: CLVS) today announced that the companies have entered into a research collaboration to evaluate ALKS 4230, Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with rucaparib, Clovis’ marketed PARP inhibitor, and …

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FDA Grants Priority Review to Genentech’s Entrectinib for Treatment of Patients with NTRK Fusion-Positive Advanced Solid Tumors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) andgranted Priority Review for entrectinib for the treatment of adult and pediatric patients with neurotrophic tropomyosin …

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Keytruda in Combination with Inlyta Reduced the Risk of Death by Nearly Half Compared to Sunitinib as First-Line Treatment for Advanced RCC

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell …

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Bayer Acquires Full Rights to Loxo Oncology’s Vitrakvi and LOXO-195

WHIPPANY, N.J., Feb. 15, 2019 /PRNewswire/ — Bayer has exercised its option, under a change-in-control clause in the collaboration agreement with Loxo Oncology, to obtain the exclusive licensing rights for the global development and commercialization, for Vitrakvi® (larotrectinib) and BAY 2731954 (LOXO-195). Both compounds are being developed globally for the treatment of adult …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Inlyta as First-Line Treatment for Advanced Renal Cell Carcinoma

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, in combination with Inlyta (axitinib), a tyrosine kinase …

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Bayer’s Investigational Darolutamide Plus ADT Significantly Extends Metastasis-Free Survival in Phase 3 Study of Non-Metastatic Castration-Resistant Prostate Cancer

WHIPPANY, N.J., Feb. 14, 2019 /PRNewswire/ — Results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) showed a statistically significant improvement in metastasis-free survival (MFS) with the investigational drug darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001).2 This translates …

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Opdivo Plus Yervoy Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced data evaluating Opdivo(nivolumab) in combination with Yervoy (ipilimumab) in patients with metastatic castration-resistant prostate cancer (mCRPC). Results from an interim analysis of the Phase 2 CheckMate -650 trial showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy …

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