Oncology

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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Daiichi Sankyo and Gustave Roussy Enter Innovative Research Collaboration for DXd ADCs DS-1062 and Patritumab Deruxtecan in Lung and Breast Cancer

TOKYO & BASKING RIDGE, N.J. & MUNICH & VILLEJUIF, France–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Gustave Roussy today announced a multi-year, multi-study research collaboration to enrich and further enable the development of DS-1062 and patritumab deruxtecan (U3-1402), two of Daiichi Sankyo’s lead DXd antibody drug conjugates (ADCs), …

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Novocure Announces Clinical Trial Collaboration with MSD to Evaluate Tumor Treating Fields Together with Keytruda in NSCLC

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) today announced it has entered into a clinical trial collaboration agreement with MSD (a tradename of Merck & Co., Inc.), through a subsidiary, to develop Tumor Treating Fields together with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for treatment of non-small cell lung cancer (NSCLC). Novocure’s …

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FDA Advisory Committee Votes in Favor of Positive Benefit/Risk Profile for GSK’s Belantamab mafodotin for Relapsed/Refractory Multiple Myeloma

  LONDON, July 14, 2020 /PRNewswire/ — GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma …

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Blueprint Medicines Collaborates with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers

CAMBRIDGE, Mass., July 14, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that it has entered into a global collaboration with Roche and Genentech, a member of the Roche Group, to develop and commercialize …

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Genentech’s Tecentriq Fails to Meet Primary Endpoint in Phase 3 Study in Women with Advanced-Stage Ovarian Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of …

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