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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
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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
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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
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FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Read the FDA announcement.
Read the Bristol Myers Squibb announcement.
Posted 2/8/2021
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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
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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
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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
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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
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FDA Approves Ponatinib Tablets for Adults with CP CML
Ponatinib (Iclusig, Takeda Oncology) is now now FDA-approved for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
More information.
Posted 1/5/2021
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FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.
Read the FDA announcement.
Read AstraZeneca's announcement.
Posted 12/21/2020