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A Look Back at FDA News from August 2019

Danielle Ternyila
Published Online:4:03 PM, Tue September 3, 2019
In August 2019, the FDA approved treatments for patients with tenosynovial giant cell tumors, non–small cell lung cancer (NSCLC), NTRK-positive solid tumors, and myelofibrosis (MF). In addition, the FDA granted priority review designations for the treatment of patients with gastrointestinal stromal tumors (GIST), prostate cancer, and mantle cell lymphoma (MCL). The FDA also granted a breakthrough desingation to an agent for the treatment of patients with chronic lymphocytic leukemia (CLL).

Here's a look back on the FDA happenings from the month of August 2019:

Pexidartinib Gets FDA Approval for Treatment of Tenosynovial Giant Cell Tumor

On August 2, 2019, the FDA granted approval to pexidartinib (Turalio) for the treatment of symptomatic tenosynovial giant cell tumor in adults patients with severe morbidity or functional limitations that are not responsive to improvement with surgery.

FDA Grants Priority Review to Avapritinib in PDGFRA+ and Fourth-Line GIST

The FDA granted a priority review on August 7, 2019, to a New Drug Application (NDA) for avapritinib as a treatment for adult patients with PDGFRA exon 18–mutant GIST, regardless of prior therapy, and in the fourth-line setting for GIST.

FDA Grants Breakthrough Designation to Acalabrutinib Monotherapy for CLL

On August 14, 2019, the FDA granted a breakthrough therapy designation to acalabrutinib (Calquence) monotherapy for the treatment of adult patients with CLL.

FDA Approves Entrectinib for ROS1+ NSCLC and NTRK+ Solid Tumors

The FDA approved entrectinib (Rozlytrek) on August 15, 2019, for the treatment of adult patients with ROS1-positive metastatic NSCLC. An accelerated approval was also granted to entrectinib for the treatment of adult and adolescent patients with solid tumors harboring an NTRK gene fusion and who have no alternative effective therapies available.

FDA Approves Fedratinib for the Treatment of Primary/Secondary Myelofibrosis

On August 16, 2019, the FDA approved fedratinib (Inrebic) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary MF, including post-polycythemia vera or post-essential thrombocythemia MF.

FDA Grants Priority Review to Enzalutamide for Metastatic Hormone-Sensitive Prostate Cancer

The FDA granted a priority review designation on August 21, 2019, to a supplemental NDA for a new indication for enzalutamide (Xtandi) as a treatment for men with metastatic hormone-sensitive prostate cancer.

FDA Grants Priority Review to Zanubrutinib for Previously Treated Mantle Cell Lymphoma

On August 21, 2019, the FDA granted a priority review to an NDA for zanubrutinib for the treatment of patients with MCL who have previously received at least 1 prior treatment.

FDA Aims To Include More Male Patients in Breast Cancer Clinical Trials With New Industry Guidelines

On August 27, 2019, the FDA drafted new industry recommendations for sponsors to encourage male inclusion in clinical trials for breast cancer.

FDA Extends Review Period for Frontline Atezolizumab Combo in Nonsquamous NSCLC

On August 30, 2019, the review period was extended by the FDA for a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) as a frontline treatment for patients with metastatic nonsquamous NSCLC who do not have EGFR or ALK aberrations. December 2, 2019 is the new action date for the sBLA.

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