Industry News

  • 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

    On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in patients whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations. 

    Read the FDA announcement.

    Read the Sanofi announcement.

    Posted 2/22/2021


  • 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 Trilaciclib for Chemotherapy-Induced Myelosuppression in ES-SCLC

    On February 16, 2021, G1 Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved "trilaciclib for injection 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 the full company announcement.

    Read the FDA announcement.

    Posted 2/16/2021



  • 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




1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
mos-missouri.com
Email Us