FDA Grants Regular Approval + New Indication to Enfortumab Vedotin-ejfv

FDA Approves Expanded Indication for Pembrolizumab for cSCC

Updated Data for Durvalumab

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. 

Posted 6/10/2021

FDA Approves Sotorasib for KRAS G12C-Mutated NSCLC

The U.S. Food and Drug Administration (FDA) has approved sotorasib (LUMAKRAS^TM, 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

FDA Approves Nivolumab for Completely Resected Esophageal or GEJ Cancer

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.

Posted 5/21/2021

Enfortumab Vedotin-ejfv Data from ASCO GU 2021

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.

Posted 5/17/2021

Positive Phase 3 Cemiplimab Results in Advanced Cervical Cancer

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

FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

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

FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Read the FDA announcement.

Read the BMS announcement.

Posted 4/16/2021

FDA Approves Isatuximab in Combination for R/R Multiple Myeloma

On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received one to three prior lines of therapy.

Read the FDA announcement.

Read the Sanofi announcement.

Posted 4/1/2021