Targeted Oncology Staff

Articles by Targeted Oncology Staff

Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA 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.

Erdafitinib (Balversa) has been granted an accelerated approval by the FDA as a treatment for&nbsp;adult patients with locally advanced or metastatic bladder cancer with an <em>FGFR3</em> or <em>FGFR2</em> alteration that has progressed on platinum-containing chemotherapy, making it the first targeted agent to receive approval for&nbsp;metastatic bladder cancer.

The clinical practice guidelines for the treatment of patients with colorectal cancer have been updated by NCCN to include the combination of&nbsp;encorafenib plus binimetinib in addition to EGFR inhibition with either cetuximab or panitumumab as a Category 2a treatment recommendation for patients with <em>BRAF</em> V600E&ndash;mutant metastatic CRC, after 1 or 2 prior therapies for metastatic disease.

Based on findings from the phase III ARAMIS trial, a new drug application for darolutamide has been submitted to the FDA seeking the&nbsp;investigational agent&#39;s approval as a treatment for&nbsp;patients with nonmetastatic castration-resistant prostate cancer, according to&nbsp;the codevelopers of the investigational agent, Bayer and Orion Corporation.<br /> &nbsp;

Based on data from the&nbsp;phase III TAGS trial,&nbsp;a supplemental new drug application seeking approval for TAS-102&nbsp;(trifluridine/tipiracil; Lonsurf)&nbsp;for use in previously treated patients with advanced or metastatic gastric adenocarcinoma,&nbsp;including cancer of the gastroesophageal junction, has been granted a priority review by the FDA.