Jason M. Broderick

June 07, 2020

The FDA has granted margetuximab an Orphan Drug designation for the treatment of patients with gastric and gastroesophageal junction (GEJ) cancer, according to MacroGenics, Inc., the manufacturer of the Fc-engineered monoclonal antibody.

June 05, 2020

The FDA has accepted a Biologics License Application (BLA) for ropeginterferon alfa-2b (P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.

May 30, 2020

The FDA has approved the combination of ramucirumab (Cyramza) and erlotinib (Tarceva) as a frontline treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.

May 28, 2020

The FDA has given a fast track designation to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

May 25, 2020

Pembrolizumab (Keytruda) combined with trastuzumab (Herceptin) and chemotherapy demonstrated promising clinical activity in patients with HER2-positive metastatic esophagogastric cancer, according to findings from a phase 2 trial published in the Lancet Oncology.

May 21, 2020

Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

May 20, 2020

The FDA has approved olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

May 16, 2020

The FDA has approved ripretinib (Qinlock) for the fourth-line treatment of patients with advanced gastrointestinal stromal tumor (GIST). Ripretinib is specifically indicated for adult patients who have received prior treatment with 3 or more kinase inhibitor therapies, including imatinib (Gleevec).

May 08, 2020

The FDA has approved the combination of olaparib (Lynparza) and bevacizumab (Avastin) for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response (PR) to first-line platinum-based chemotherapy with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)–positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

May 08, 2020

The vaccine BVAC-C demonstrated durable antitumor activity in patients with HPV 16– or HPV 18–positive recurrent cervical cancer, according to findings presented at the 2020 AACR Virtual Annual Meeting I.