Oncology

Guardant Health and Radius Health Partner to Develop Liquid Biopsy Companion Diagnostic for Elacestrant

REDWOOD CITY, Calif., July 30, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Radius Health, Inc. (Radius, Nasdaq: RDUS) to pursue regulatory approval of the Guardant360® CDx as a companion diagnostic for elacestrant (RAD1901), an investigational selective estrogen receptor degrader (SERD) being studied in the treatment …

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AstraZeneca’s Tagrisso Granted Breakthrough Therapy Designation by the FDA for Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s TAGRISSO® (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The Food and Drug Administration’s (FDA) BTD is …

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FDA Grants Breakthrough Therapy Designation to Takeda’s Pevonedistat for Treatment of Higher-Risk Myelodysplastic Syndromes

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat, a first in class NEDD8-activating enzyme (NAE) inhibitor, could be …

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Merck Announces Two FDA Regulatory Milestones for Keytruda in Triple-Negative Breast 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 accepted two new supplemental Biologics License Applications (sBLAs) for KEYTRUDA, Merck’s anti-PD-1 therapy. The FDA has accepted and granted priority review for a new sBLA …

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Bristol Myers and bluebird bio Announce Submission of BLA to the FDA for Idecabtagene Vicleucel for Relapsed and Refractory Multiple Myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell …

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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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