FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC

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.

Posted 7/27/2021

FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer

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. 

Posted 7/22/2021

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

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

FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Read the FDA announcement.

Read the Bristol Myers Squibb announcement.

Read the bluebird bio, Inc. announcement.

Posted 3/29/21

FDA Approves Trastuzumab-qyyp Biosimilar

The U.S. Food and Drug Administration approved the 150 mg single-dose vial of trastuzumab-qyyp (Trazimera^®, Pfizer)—a biosimilar to Herceptin^® (trastuzumab).

Read the full prescribing information.

Posted on 3/11/2021

FDA Approves Bevacizumab-bvzr for New Indication

The U.S. Food and Drug Administration approved the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of bevacizumab-bvzr (Zirabev^®, Pfizer). 

Read the full prescribing information.

Posted on 3/11/2021

FDA Expands Lorlatinib Approval to Include ALK-Positive NSCLC

On March 3, 2021, the U.S. Food and Drug Administration (FDA) expanded lorlatinib's indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorlatinib is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Read Pfizer's announcement.

Posted 3/4/21

FDA Approves Melphalan Flufenamide for R/R MM

On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Read Oncopeptides' announcement.

Posted 3/1/21

FDA Approves Cemiplimab-rwlc Monotherapy for Advanced NSCLC

FDA Approves Cemiplimab-rwlc for Advanced Basal Cell Carcinoma

On February 9, the Food and Drug Administration approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo^®, Regeneron/Sanofi) as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

Read the press release. 

Posted on 2/17/2021

FDA Approves Cemiplimab-rwlc as First Immunotherapy for Advanced BCC

On February 9, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic basal cell carxinoma previously treated with a HHI or for whom a HHI is not appropriate.

Read the FDA announcement.

Read Sanofi and Regeneron's announcements.

Posted 2/10/21

FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

FDA Approves Tepotinib for Metastatic NSCLC

On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read the FDA announcement.

Read Merck KGaA's announcement.

Posted 2/4/21