FDA Okays COVID-19 Vaccine Booster Shot for Immunocompromised Patients
An appropriate vaccination strategy will follow.
Diagnosis & Disease Information
FDA Approves Therapy for Advanced Urothelial Cancer
Padcev is the first antibody-drug conjugate approved for advanced urothelial cancer patients.
Cancer Risk From Recalled ARBs “Likely Much Lower” Than Initially Estimated, Says FDA
The FDA clarified that the risk of cancer associated with exposure to nitrosamine impurities was likely lower than what was initially assessed.
Tecentriq Plus Chemotherapy Approved for Initial Treatment of Extensive-Stage Small Cell Lung Cancer
The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab; Genentech), in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Biosimilar Cancer Treatment Ontruzant Gets FDA Approval
Prior to treatment, HER2 testing using FDA-approved tests should be performed.
FDA Approves Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer
This latest approval now makes enzalutamide the only FDA-approved oral medication indicated for both metastatic and nonmetastatic castration-resistant prostate cancer.
FDA’s Accelerated Approval Pathway Needs Active Management
Results from postmarketing trials for drugs approved through FDA’s accelerated approval pathway need to be produced in a more timely fashion to reveal the true benefit — or lack thereof — of the drugs approved through these expedited channels.
FDA Approves Encorafenib Plus Binimetinib for BRAF V600E, V600K Mutation-Positive Melanoma
The FDA based their approval on findings from the phase 3 COLUMBUS study, in which researchers randomly assigned patients with BRAF V600-mutant melanoma to receive encorafenib plus binimetinib, encorafenib, or vemurafenib.
FDA Grants Priority Review to Dabrafenib and Trametinib Combination for Resected Melanoma
The drug combination was studied in patients with BRAFV600E/K mutations in the phase 3 COMBI-AD study, the results of which led to the FDA’s Priority Review designation.
Apalutamide Granted Priority Review for Castration-resistant Prostate Cancer
Apalutamide is a next-generation, orally administered inhibitor of the androgen receptor.
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