On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.
Read Merck's announcement.
On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Read the FDA announcement.
Read the Merck announcement.
Read the Eisai Inc. announcement.
Durvalumab (Imfinzi®, AstraZeneca) offers the best chance for long-term survival in a curative intent setting. This update comes after the post-hoc analysis of 5-year overall and progression-free survival data had been released for the PACIFIC trial, a large, Phase III, randomized, double-blind, placebo-controlled, multicenter study of 713 patients with unresectable Stage III NSCLC. The primary overall survival analysis was reported at 2 years (25.2 months median follow-up). For more information, click here.
The U.S. Food and Drug Administration (FDA) has approved sotorasib (LUMAKRASTM, Amgen) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Sotorasib has received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Read press release.
Posted on 6/1/2021
On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
Read the FDA announcement.
Read the Bristol Myers Squibb announcement.
Enfortumab vedotin-ejfv (PADCEV®, Astellas) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.
PADCEV received accelerated approval based on the EV-201 trial, a single-arm, multicenter trial of 125 patients with locally advanced or metastatic urothelial cancer who had previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. Read more.
On Wednesday, May 12, Regeneron Pharmaceuticals, Inc. and Sanofi announced the presentation of positive results from the Phase 3 trial investigating the PD-1 inhibitor cemiplimab (Libtayo®) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy.
The data were shared as part of a European Society for Medical Oncology Virtual Plenary and add to previously reported data showing an improvement in overall survival (OS) with Libtayo compared to chemotherapy. The data will form the basis of regulatory submissions in 2021.
Read the press release.
Posted on 5/12/2021
The Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.
Read the prescribing information and medication guide.
Posted on 4/30/2021