A Look Back at FDA News from October 2019

In October 2019, the FDA approved a new treatment option for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, as well as a new dosing regimen for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC). An expanded indication for romiplostim (Nplate) was also approved allowing for the treatment of patients with newly diagnosed immune thrombocytopenia (ITP). Additionally, the FDA granted breakthrough therapy designations to 2 therapies as well as an orphan drug designation, a priority review, and 2 fast track designations.

The FDA also approved a labeling supplement to add safety information for neratinib (Nerlynx) in HER2-positive early-stage breast cancer, and a draft guidance was issued, proposing labeling recommendations for breast implant manufacturers.

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

FDA Approves Labeling Supplement on Prophylaxis for Neratinib in HER2+ Breast Cancer

On October 3, 2019, the FDA approved a labeling supplement for neratinib (Nerlynx) for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer. This supplement adds safety information based on interim findings from the phase II CONTROL trial.

FDA Grants Breakthrough Designation to Niraparib for Metastatic CRPC

The FDA granted a breakthrough therapy designation on October 3, 2019, for the treatment of patients withBRCA1/2-mutant metastatic castration-resistant prostate cancer who had previously received a taxane chemotherapy and androgen receptor-targeted therapy.

Cobimetinib Granted FDA Breakthrough Therapy Designation for Histiocytic Neoplasms

MEK inhibitor cobimetinib (Cotellic) received a breakthrough therapy designation from the FDA on October 4, 2019, for the treatment of adult patients with histiocytic neoplasms who do not harbor aBRAFV600E mutation.

Duvelisib Gains FDA Orphan Drug Designation for T-Cell Lymphomas

On October 4, 2019, the FDA granted an orphan drug designation to duvelisib (Copiktra) for the treatment of patients with T-cell lymphomas.

FDA Fast Track Designation Granted to Navicixizumab for Heavily Pretreated Ovarian Cancer

The FDA granted a fast track designation on October 7, 2019, to navicixizumab (OMP-305B83) for the treatment of patients with high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received ≥3 prior therapies and/or prior bevacizumab (Avastin).

FDA Grants Priority Review of DS-8201 for HER2+ Metastatic Breast Cancer

On October 17, 2019, the FDA granted a priority review designation to [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer.

FDA Approves Romiplostim for Earlier Use in Adults With ITP

The FDA approved an expanded indication for romiplostim on October 18, 2019, for the treatment of adult patients with ITP to include newly diagnosed patients and patients with persistent ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Bemcentinib Granted FDA Fast Track Designation for R/R AML

On October 22, 2019, the FDA granted a fast track designation to bemcentinib (BGB324), a first-in-class AXL inhibitor, for the treatment of elderly patients with relapsed/refractory acute myeloid leukemia.

FDA Approves New Aprepitant Dosing Regimen for CINV After MEC

The FDA approved a supplemental New Drug Application (sNDA) for a single dose of aprepitant (Cinvanti) injectable emusion for intravenous use on October 23, 2019, in patients receiving MEC for the prevention of acute and delayed CINV.

FDA Approves Niraparib for Previously Treated HRD+ Advanced Ovarian Cancer

On October 23, 2019, the FDA approved niraparib (Zejula) for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with at least 3 prior lines of chemotherapy and whose cancer is associated with homologous recombination deficiency positivity.

Updated BLA Submitted to FDA for Eflapegrastim as Chemotherapy-Induced Neutropenia Treatment

An updated Biologics License Application was submitted to the FDA on October 24, 2019, for eflapegrastim (Rolontis) for the treatment of neutropenia in patients with cancer receiving myelosuppression drugs.

FDA Considers New Warning and Label Recommendations for Breast Implants

The FDA issued a draft guidance on October 28, 2019, that proposes labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.

Avapritinib NDA Being Split in Two, PDGFRA+ GIST Indication Continuing Review