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 the PD-L1 IHC 22C3 pharmDx Assay for NSCLC

On February 22, 2021, the U.S. Food and Drug Administration (FDA)  approved the PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying patients with NSCLC with tumor PD-L1 expression of Tumor Proportion Score greater than or equal to 50 percent for treatment with Libtayo® (cemiplimab-rwlc).

Read Agilent Technologies Inc. announcement.

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