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Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Seattle Genetics From: biospace.com – FDA Action Date is August 20, 2020; Application Under FDA’s Real-Time Oncology Review (RTOR) and Orbis Pilot Programs – – Supported by Results from Pivotal HER2CLIMB Trial; First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases – Seattle Genetics, Inc.. (Nasdaq:SGEN) today announced that …

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Gilead to get speedy FDA review for second CAR-T cell therapy in lymphoma

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The biotech company’s Kite Pharma subsidiary said the FDA had granted priority review for KTE-X19 in mantle cell lymphoma. The company already markets the CAR-T Yescarta for diffuse large B-cell lymphoma. A subsidiary of Gilead Sciences could have its second CAR-T cell therapy on the market by this summer if the Food and Drug Administration …

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FDA Grants Priority Review to Capmatinib in METex14+ NSCLC

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com The FDA has granted a priority review designation to a new drug application (NDA) for capmatinib (INC280) for use as treatment for newly diagnosed and previously treated patients with locally advanced or metastatic MET exon14 skipping (METex14)—mutated non–small cell lung cancer (NSCLC).1 The priority designation, which will expedite the review and development of capmatinib …

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Calibr and AbbVie’s switchable cancer CAR-T begins clinical trials

In Clinical Studies News by Barbara Jacoby

By: Richard Staines From: pharmaphorum.com California biotech Calibr and research partner AbbVie have clearance to start clinical trials of a new CAR-T technology, involving “switchable” cells that aim to eliminate the life-threatening side-effects that have hampered this class of therapy so far. La Jolla-based Calibr said the FDA had accepted its Investigational New Drug (IND) filing for the new novel …

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Checkpoint Therapeutics Announces Confirmation of Registration Path for Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma

In Clinical Studies News by Barbara Jacoby

Source: Checkpoint Therapeutics From: checkpointtx.com FDA feedback supports plan to submit Biologics License Application (BLA) based on data from ongoing Phase 1 trial One-third enrollment complete in cohort of patients with metastatic cutaneous squamous cell carcinoma Potential for cosibelimab to be differentiated and lower-cost alternative to available anti-PD-1/L1 mAbs Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted …

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FDA Grants Priority Review to Olaparib Plus Bevacizumab as Frontline Maintenance in Ovarian Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of olaparib (Lynparza) and bevacizumab (Avastin) for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response (PR) to first-line platinum-based chemotherapy with bevacizumab.1 The designation is based on results from …

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FDA Approves Drugs Faster Than Ever but Relies on Weaker Evidence, Researchers Find

In Clinical Studies News by Barbara Jacoby

Source: Sydney Lupkin, NPR From: pharmavoice.com The Food and Drug Administration has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker, according to new research published Tuesday. As a result, there are more cures and treatments on the market but less proof that they …

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DA grants orphan drug designation to OBI-999 for pancreatic cancer

In Clinical Studies News by Barbara Jacoby

From: healio.com The FDA granted orphan drug designation to the antibody-drug conjugate OBI-999 for the treatment of pancreatic cancer, according to a press release from the agent’s manufacturer. OBI-999 (OBI Pharma) targets Globo H, a glycolipid antigen expressed in up to 15 epithelial cancers. Preclinical xenograft animal models of pancreatic, lung, gastric and breast cancers showed OBI-999 induced profound tumor …

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FDA approves new treatment, Enhertu, for patients with HER2-positive breast cancer

In Clinical Studies News by Barbara Jacoby

From: outbreaknewstoday.com The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human …

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Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: Business Wire From: apnews.com Seattle Genetics, Inc. (Nasdaq:SGEN) today announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients …