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 Grants Accelerated Approval to Dostarlimab-gxly

On April 22, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.

Read the FDA announcement.

Read the GlaxoSmithKline announcement.

Posted 4/23/2021

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 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

Texas Medicaid Designates Pegfilgrastim-cbqv on the Preferred Drug List

For 2021, Texas Medicaid has designated pegfilgrastim-cbqv (Udenyca^®, Coherus Biosciences) the preferred pegfilgrastim on the Preferred Drug List (PDL). Udenyca^® coverage details are available here.

Please contact marketaccess@coherus.com for additional information.

Posted 3/15/2021

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

G1 Therapeutics and Boehringer Ingelheim Announce Commercial Availability of Trilaciclib

G1 Therapeutics, Inc. and Boehringer Ingelheim announced that COSELA™(trilaciclib) for injection is now available in the U.S. 

On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved COSELA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy.

Read press release.

Posted on 3/10/2021

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