Oncology

Phase 3 Study of Bristol Myers Squibb’s Idhifa in Patients with Relapsed or Refractory Acute Myeloid Leukemia Fails to Meet its Primary Endpoint

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE:BMY) today announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall …

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Turning Point Therapeutics Granted Fast Track Designation for Repotrectinib in NTRK-Positive TKI-Pretreated Advanced Solid Tumors

SAN DIEGO, Aug. 24, 2020 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the Food and Drug Administration (FDA) granted a third Fast-Track designation to its lead drug candidate, repotrectinib. The designation was granted …

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Exelixis Announces Submission of sNDA to the FDA Cabometyx in Combination with Opdivo for Advanced Renal Cell Carcinoma

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). “We are excited to complete our first regulatory submission for CABOMETYX in combination …

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Odonate Announces Positive Top-line Results from its Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer

SAN DIEGO–(BUSINESS WIRE)–Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, today announced positive top-line results from CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC). CONTESSA is a …

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Phase 3 Trial of Onconova’s IV Rigosertib Fails to Meet Primary Endpoint in Patients with Higher-Risk Myelodysplastic Syndromes

NEWTOWN, Pa., Aug. 24, 2020 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) a biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that INSPIRE, the company’s pivotal Phase 3 study assessing the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients, did …

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Novartis Announces Phase 3 Study of Sparalizumab in Combination with Tafinlar + Mekinist Fails to Meet its Primary Endpoint in Advanced Melanoma

Basel, August 22, 2020 — Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar® (dabrafenib) and Mekinist® (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. The trial was conducted among untreated patients with unresectable (Stage IIIC) or …

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FDA Approves Kyprolis in Combination with Darzalex and Dexamethasone for Patients with Relapsed/Refractory Multiple Myeloma

THOUSAND OAKS, Calif., Aug. 20, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX® (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed …

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Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies, Starting with Treatments for COVID-19 and Cancer

SAN DIEGO AND BOSTON, Aug. 20, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) and SmartPharm Therapeutics, Inc. (“SmartPharm”) announced today the signing of a merger agreement under which Sorrento will acquire SmartPharm, a gene-encoded therapeutics company developing non-viral DNA and RNA gene delivery platforms for COVID-19 and …

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FDA Grants Fast Track Designation to Kazia’s Paxalisib for Treatment of Glioblastoma

SYDNEY, Aug. 20, 2020 /PRNewswire/ — Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kazia’s paxalisib (formerly GDC-0084) for the treatment of glioblastoma, the most common and …

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Puma Biotechnology Announces Publication of Interim Results of Phase II Neratinib Trial in Patients with HER2+ Breast Cancer

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the publication of interim results from its Phase II CONTROL trial of neratinib in the September 2020 Issue (Volume 31, Issue 9) of Annals of Oncology. The publication entitled, “Improved Tolerability of Neratinib in Patients with HER2+ Early-Stage Breast Cancer: …

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