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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
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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.
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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