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FDA Workshop provides updates on new drugs for breast cancer

In In The News by Barbara Jacoby

From: sabcsmeetingnews.org The Food and Drug Administration’s Breakthrough Therapy Designation (BTD) pathway produced three new breast cancer treatments in 2020, including two antibody-drug conjugates. “Antibody-drug conjugates are an important new drug class,” said Angela DeMichele, MD, MSCE, Jill & Alan Miller Endowed Chair in Breast Cancer Excellence, Professor of Medicine and Co-Leader of the Breast Cancer Center at the University …

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State-of-the-art technology provides high levels of accuracy in breast cancer diagnosis

In In The News by Barbara Jacoby

Source: University of Leeds From: news-medical.net State-of-the-art technology which helps doctors more accurately diagnose breast cancer has been hailed as a breakthrough by the US Food & Drugs Administration (FDA) for its exceptional potential clinical value in improving patient care. The 4D Q-plasia OncoReader Breast uses digitized pathology slides of breast cancer tissue to diagnose disease with improved accuracy, effectively …

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FDA Issues Efficacy and Safety Warning Based on Results From IMpassion131

In Clinical Studies News by Barbara Jacoby

By: Victoria Forster, PhD From: cancertherapyadvisor.com On September 8, 2020, the US Food and Drug Administration (FDA) issued an alert regarding the IMpassion131 trial (ClinicalTrials.gov Identifier: NCT03125902), citing efficacy and potential safety concerns.1 The trial which aimed to recruit 600 patients was testing the combination of atezolizumab and paclitaxel in patients with advanced or metastatic triple-negative metastatic breast cancer (mTNBC). …

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FDA Recommends Clinical Trials Include Premenopausal Women With Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com The FDA issued a draft guidance that encourages the inclusion of premenopausal women with breast cancer in clinical trials, which will in order to help researchers determine the efficacy of a hormonal drug or biological products for this population along with others. The FDA has issued a draft guidance that encourages the inclusion of premenopausal …

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FDA Approvals Sought for 2 Pembrolizumab Indications in TNBC

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com The FDA has accepted 2 supplemental biologics applications (sBLAs) for pembrolizumab (Keytruda) in patients with triple-negative breast cancer (TNBC); these are the first US applications for the anti–PD-1 therapy in breast cancer, according to an announcement from Merck, the drug developer.1 Specifically, the regulatory agency has accepted and granted priority review to a new sBLA …

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FDA Okays New CAR T Therapy, First for Mantle Cell Lymphoma

In Clinical Studies News by Barbara Jacoby

By: Nick Mulcahy From: medscape.com The US Food and Drug Administration (FDA) today granted accelerated approval to brexucabtagene autoleucel (Tecartus, Kite Pharma), the first approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The new agent is the second approved CAR T cell product developed by Kite and follows …

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Janssen Pharmaceutical Bispecific Antibody Granted Breakthrough Designation for Lung Cancer Treatment

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com Janssen Pharmaceutical Companies, a unit of Johnson & Johnson, said on Tuesday that its investigational drug JNJ-61186372 (JNJ-6372) has been granted breakthrough therapy designation by the US Food and Drug Administration. The drug is being evaluated in non-small cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed on or after …

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GSK gets expedited FDA review for multiple myeloma drug

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The company anticipates the FDA to rule on the drug, belantamab mafodotin, in the first half of this year. If approved, it would be the first therapy targeting the cell-surface protein BCMA to hit the market. Several other anti-BCMA drugs are also in development. A British drugmaker said it could become the first company on …

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GSK’s sNDA for Ovarian Cancer Drug Zejula Accepted by FDA

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com GlaxoSmithKline said Monday that the supplemental new drug application for niraparib (Zejula) as a first-line maintenance treatment for chemotherapy-responsive advanced ovarian cancer was accepted by the US Food and Drug Administration. GSK is seeking approval for the drug in an all-comer patient population, regardless of whether they have tumors that are homologous recombination deficient (HRD). …

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SELLAS Life Sciences Provides Regulatory Update for Nelipepimut-S (NPS) for Triple Negative Breast Cancer (TNBC) Following FDA Feedback

In Clinical Studies News by Barbara Jacoby

Source: SELLAS Life Sciences Group From: globenewswire.com Regulatory clarity on registration-enabling Phase 3 study design of NPS in combination with trastuzumab in TNBC patients in the adjuvant setting enhances business development efforts SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range …