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Oncology

FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The …

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Argos Discontinues Late-Stage Trial of Investigational Vaccine for Patients with Metastatic Renal Cell Carcinoma

DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) — Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in …

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Personal Genome Diagnostics’ TMB Analysis Shows Promising Checkpoint Inhibitor Efficacy in Early-Stage Lung Cancer Study

BALTIMORE, April 19, 2018 /PRNewswire/ — Personal Genome Diagnostics Inc. (PGDx) today reported that its whole exome analysis platform contributed to an important new study published in the New England Journal of Medicine (NEJM) showing promising efficacy for a leading checkpoint inhibitor in early stage lung cancer.1 The study also …

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FDA Grants Priority Review to the sBLA for Opdivo in Previously Treated Patients with Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is …

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FDA Approves AstraZeneca’s Tagrisso as First-Line Therapy for EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The …

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FDA Approves Opdivo + Yervoy Combination as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).1,2 In the Phase 3 …

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Shire Sells Oncology Business to Servier for $2.4 Billion

Dublin, Ireland – April 16, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) the leading global biotechnology company focused on rare diseases announces today that it has entered into a definitive agreement with Servier S.A.S. (“Servier”) to sell its Oncology business for $2.4 billion. Shire’s Oncology business includes in-market products ONCASPAR® …

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Keytruda-Pemetrexed-Platinum Chemotherapy Combination Significantly Improved Overall Survival in Late-Stage NSCLC Study

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). …

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Opdivo In Combination with Yervoy Reduces Risk of Progression or Death by 42% Versus Chemo in First-Line Lung Cancer Patients

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced initial results from the pivotal Phase 3 study, CheckMate -227, evaluating the Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated …

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Bristol-Myers Squibb and Illumina Partner for Companion Diagnostics for Oncology Immunotherapies

NEW YORK & SAN DIEGO–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Illumina, Inc. (NASDAQ: ILMN) today announced a collaboration that will utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb’s oncology portfolio. The companies plan to develop a diagnostic version of the Illumina …

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