Jason M. Broderick

Articles

Margetuximab Granted Orphan Drug Status for Gastric Cancer

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.

FDA Accepts BLA for Ropeginterferon Alfa-2b for PV Treatment

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.

FDA Approves Ramucirumab + Erlotinib for Firstline EGFR+ NSCLC

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.

Immunotherapy-Based Triplet Is Active in HER2+ Esophagogastric 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.

sNDA Submitted to the FDA for Earlier Selinexor Treatment in Myeloma

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.

FDA Approves Olaparib for mCRPC Subset

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).

FDA Approves Ripretinib for Advanced GIST Treatment

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).

FDA Approves Olaparib Plus Bevacizumab for Frontline Maintenance Treatment of HRD+ Ovarian Cancer

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.

Vaccine Promising in Cervical Cancer

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.