A Look Back at FDA News in the Month of March

April 3, 2018

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.

Additionally, the FDA granted a priority review designation to 3 promising agents: pembrolizumab (Keytruda) for advanced cervical cancer, enzalutamide (Xtandi) for nonmetastatic castrastion-resistant prostate cancer, and the combination of nivolumab plus ipilimumab (Yervoy) for microsatellite instability-high or mismatch repair deficient cases of metastatic colorectal cancer.

Here’s a look back on the FDA happenings for the month of March 2018:

Pamrevlumab Granted Fast Track Designation by FDA for Locally Advanced Pancreatic Cancer

On March 2, the FDA granted a Fast Track designation to pamrevlumab (FG-3019) for the treatment of patients with locally advanced, unresectable pancreatic cancer, FibroGen, the manufacturer of the first-in-class anti-CTGF, announced.

FDA Grants Approval to 4-Week Nivolumab Dosing Schedule

The FDA approved a 4-week dosing schedule for the PD-1 inhibitor nivolumab (Opdivo) across several indications on March 6. The indications include: melanoma, non—small cell lung cancer, renal cell carcinoma, urothelial carcinoma, Hodgkin lymphoma, squamous cell carcinoma of the head and neck, hepatocellular carcinoma.

FDA Panel Recommends Approval of Blinatumomab for MRD+ ALL

On March 7, the FDA's Oncologic Drugs Advisory Committee recommended approval of blinatumomab (Blincyto) for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia (ALL). The agent was approved by the FDA later in the month.

FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer

On March 9, 23andMe, Inc. received authorization from the FDA for the first-ever direct-to-consumer genetic test for cancer risk. The authorization allows customers to test themselves for information on 3 genetic variants found on theBRCA1and BRCA2genes, which are associated with higher risk for breast, ovarian, and prostate cancer.

Pembrolizumab Granted Priority Review by FDA for Advanced Cervical Cancer

Pembrolizumab (Keytruda) was granted a priority review by the FDA on March 13 for the treatment of advanced cervical cancer with disease progression on or after chemotherapy. The agency has set a deadline of June 28, 2018 to make its decision.

FDA Places Hold on Axalimogene Filolisbac Plus Durvalumab Trial in Cervical, Head and Neck Cancer

The FDA placed a clinical hold on a phase I/II study of axalimogene filolisbac (AXAL) and durvalumab (Imfinzi) on March 13, according to an announcement by Advaxis, the manufacturer of axalimogene filolisbac. The study is evaluating the combination in patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck squamous cell carcinoma (HNSCC).

Erdafitinib Granted Breakthrough Therapy Designation by FDA for Urothelial Carcinoma

Based on the phase II study BLC2001, erdafitinib was granted a breakthrough therapy designation by the FDA on March 15 for the treatment of metastatic urothelial carcinoma, according to Janssen, the manufacturer of the oral pan-FGFR tyrosine kinase inhibitor.

Enzalutamide Granted FDA's Priority Review for Nonmetastatic CRPC

On March 19, a supplemental new drug application (sNDA) for enzalutamide (Xtandi) for the treatment of men with nonmetastatic castration-resistant prostate cancer (CRPC) was granted a priority review by the FDA, according to Pfizer and Astellas, the companies developing the antiandrogen agent.

Brentuximab Vedotin Approved by FDA for Hodgkin Lymphoma

Based on findings from the phase III ECHELON-1 trial, brentuximab vedotin (Adcetris) was approved by the FDA on March 20 for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma, according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.

Enfortumab Vedotin Granted FDA's Breakthrough Designation for Treatment of Urothelial Carcinoma

On March 26, enfortumab vedotin was granted a breakthrough therapy designation by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint therapy. These findings have been released by Seattle Genetics and Astellas, the manufacturers of the antibody-drug conjugate (ADC).

Priority Review Granted by FDA for Nivolumab Plus Ipilimumab Combo for MSI-H/dMMR CRC

On March 27, a supplemental biologics license application was granted priority review by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases of metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

Blinatumomab Granted FDA Approval for MRD+ ALL

On March 29, blinatumomab (Blincyto) was granted an accelerated approval by the FDA for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).