Jason M Broderick

Articles by Jason M Broderick

The Food and Drug Administration has approved the PI3K inhibitor Piqray (alpelisib) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

The FDA has granted an accelerated approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

The Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, also known as EPd, for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.

The FDA has granted a priority designation to a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) for use in combination with Gazyva (obinutuzumab) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The Food and Drug Administration (FDA) has approved Vizimpro (dacomitinib) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations, according to Pfizer, the manufacturer of the pan-human EGFR tyrosine kinase inhibitor (TKI).

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor (PI).