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

New FDA-Approved Indication for Crizotinib Capsules

The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for crizotinib (Xalkori^®, Pfizer) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic leukemia kinase-positive. 

Read the Full Prescribing Information.

Read the Press Release.

Posted 1/26/2021

FDA Approves Nivolumab + Cabozantinib for Advanced RCC

On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Read Bristol Myers Squibb's announcement.

Read the FDA announcement.

Posted 1/22/2021

FDA Approves Crizotinib for Children and YA Patients with R/R ALCL

On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL.

Read the FDA announcement.

Read Pfizer's announcement.

Posted 1/15/2021

FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

Durvalumab Dosing Update

Durvalumab (Imfinzi^®, AstraZeneca) has been approved in the U.S. for an additional dosing option for patients with a body weight of 30 kg and more: 1500 mg administered intravenously every four weeks in the approved indication of unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy. Patients with body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks.

Read the press release.

Posted on 12/15/2020. 

FDA Approves Additional Indication for Pembrolizumab

Pembrolizumab (Keytruda^®, Merck) has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Select patients for treatment with KEYTRUDA in combination with chemotherapy based on the presence of positive PD-L1 expression in:
- locally recurrent unresectable or metastatic TNBC

Read prescribing information and Medication Guide.

Posted on 12/07/2020