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:
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.
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, nonsmall cell lung cancer, renal cell carcinoma, urothelial carcinoma, Hodgkin lymphoma, squamous cell carcinoma of the head and neck, hepatocellular carcinoma.
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.
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 (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.
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).
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.
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.
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.
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).
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.
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).