FDA Specialty Approvals

New FDA Approvals: FDA Grants Additional Approval to Verzenio | Nov. 16, 2021

Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ­>20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.

New FDA Specialty Approvals

✦ July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kin...

New FDA Specialty Approvals

✦ July 9: The FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who ...

New FDA Specialty Approvals

✦ June 7: The FDA granted another indication to Alexion Pharmaceuticals, Inc.’s Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in children at least 1 month old and ad...

New FDA Specialty Approvals

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of loca...

New FDA Specialty Approvals

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of loca...

New FDA Specialty Approvals

✦ April 6: The FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people...

New FDA Specialty Approvals

✦ Feb. 3: The FDA gave accelerated approval to Merck KGaA unit EMD Serono, Inc.’s Tepmetko (tepotinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithel...

New FDA Specialty Approvals

✦ Jan. 14: The FDA granted an additional indication to Pfizer Inc.’s Xalkori (crizotinib) to treat children at least 1 year old and young adults with relapsed or refractory, systemic anaplastic large cell lympho...

New FDA Specialty Approvals

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, ...