A Look Back at FDA News from September 2019

In September 2019, the FDA approved new treatment options for patients with endometrial carcinoma, prostate cancer, and multiple myeloma. The FDA also expanded the indication for the Cologuard noninvasive screening test for colorectal cancer (CRC). During the month there were 2 breakthrough therapy designations, 2 fast track designations, 1 orphan drug designation, and 1 priority review granted.

The FDA also announced a warning for rare, severe adverse event associated with CDK4/6 inhibition in patients with advanced breast cancer.

Here’s a look back on the FDA happenings from the month of September 2019:

FDA Grants Breakthrough Designation to Nirogacestat for Desmoid Tumors

On September 3, 2019, the FDA granted a breakthrough therapy designation to the investigational gamma-secretase inhibitor, nirogacestat (PF-03084014), for the treatment of adult patients with progressive, unresectable, recurrent, or refractory desmoid tumors or deep fibromatosis.

FDA Grants Neratinib Orphan Drug Designation for Breast Cancer Brain Metastases

On September 3, 2019, neratinib (Nerlynx) received an orphan drug designation from the FDA for the treatment of patients with breast cancer—related brain metastases.

FDA Grants Capmatinib Breakthrough Designation forMET+ NSCLC

The FDA granted a breakthrough therapy designation to capmatinib for the frontline treatment of patients withMETexon 14 skipping mutation—positive non–small cell lung cancer (NSCLC) on September 6, 2019.

FDA Grants AMG 510 Fast Track Designation forKRASG12C+ NSCLC

AMG 510 received a fast track designation on September 9, 2019, for the treatment of patients with previously treated metastatic NSCLC harboring aKRASG12C mutation.

FDA Grants Breakthrough Designation to Tepotinib For Previously TreatedMETex14+ NSCLC

On September 11, 2019, the FDA granted a breakthrough therapy designation to tepotinib, an investigational MET inhibitor, for the treatment of patients with metastatic NSCLC who harbor aMETexon 14 skipping alteration and have progressed following platinum-based therapy.

FDA Accepts sNDA for Neratinib Combo for Third-Line HER2+ Metastatic Breast Cancer

The FDA accepted a supplemental New Drug Application for the use of neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer following failure on at least 2 prior lines of HER2-directed therapy on September 11, 2019.

FDA Grants Priority Review to Enfortumab Vedotin for Advanced Urothelial Cancer

On September 16, 2019, the FDA granted priority review to a Biologics License Application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting and a PD-1/PD-L1 checkpoint inhibitor.

FDA Warns of Lung Inflammation From CDK4/6 Inhibitor Use in Breast Cancers

The FDA issued a warning on September 16, 2019, for a rare, but severe, lung inflammation that could be caused by CDK4/6 inhibitors, including palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio), in patients with advanced breast cancers.

FDA Approves Pembrolizumab/Lenvatinib for Advanced Endometrial Carcinoma

The combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) received an accelerated approval from the FDA on September 17, 2019, for the treatment of patients with advanced endometrial cancer who have disease progression following prior systemic therapy.

FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer

On September 17, 2019, the FDA approved apalutamide (Erleada) for the treatment of patients with metastatic castration-sensitive prostate cancer.

FDA Grants Fast Track Designation to Abexinostat for Fourth-Line Follicular Lymphoma

The FDA granted a fast track designation on September 23, 2019, to abexinostat for the treatment of patients with relapsed/refractory follicular lymphoma in the fourth-line setting.

FDA Expands Indication for CRC Screening Test to Include Younger Patients

On September 23, 2019, the FDA expanded the indication for the Cologuard noninvasive screening test for colorectal cancer (CRC) to include eligible patients with an average risk of developing CRC who are between the ages of 45 and 49.

FDA Approves Daratumumab + VTD Combo for Frontline Multiple Myeloma

The FDA approved the combination of daratumumab (Darzalex) plus bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone (VTd) on September 26, 2019, for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Imetelstat Granted Fast Track Designation by the FDA