This latest approval now makes enzalutamide the only FDA-approved oral medication indicated for both metastatic and nonmetastatic castration-resistant prostate cancer.
Treatment chart with usual dosage, strength, and formulation of FDA approved medications for breast cancer.
Colorectal cancer treatment regimen chart.
Non-small cell lung cancer (NSCLC) treatment regimen chart.
FDA-Approved treatment options for individuals with ovarian cancer including dosing.
Approved prostate cancer drug treatments including formulations and usual dosing.
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.
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.
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 is a next-generation, orally administered inhibitor of the androgen receptor.
Approval was based on results from the randomized phase 3 BFORE trial, which showed a higher MMR rate in patients treated with bosutinib than in those treated with imatinib.
The FDA based its approval on data collected from the open-label, phase 2 CABOSUN study, for which researchers randomly assigned 157 patients with RCC to receive oral cabozantinib or sunitinib.
FDA Accepts Supplemental New Drug Application for Osimertinib as First-line Treatment in EGFR-mutant NSCLCDecember 18, 2017
Data from FLAURA may position osimertinib as the first-line standard of care for patients with EGFR-mutant NSCLC.
Dabrafenib plus trametinib is the first adjuvant therapy indicated specifically for melanoma with the BRAFV600 mutation.
The FDA granted orphan drug designation today to TPX-0005 — a small molecule kinase inhibitor — for the treatment of NSCLC with ALK, ROS1, or NTRK rearrangements.
The NDA is based on findings from the international, double-blind, phase 3 ENGOT-OV16/NOVA trial.
The FDA has approved a sNDA to update the US prescribing information for Xtandi (enzalutamide) capsules.
Cabozantinib (Cabometyx) has recieved FDA approval for treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.
The year 2015 brought treatment advances for patients with myriad cancer types, as reflected in U.S. Food and Drug administration approvals.
A comprehensive review of the 6 drugs approved for the treatment of patients with metastatic squamous and nonsquamous non-small cell lung cancer.
The FDA has granted alectinib (ALECENSA) accelerated approval for the treatment of patients with non-small cell lung cancer.
The FDA granted accelerated approval to Ibrance (palbociclib) for human epidermal growth factor receptor (HER2)-negative metastatic breast cancer.
The FDA has granted approval to Lynparza for the treatment of BRCA mutated advanced ovarian cancer.
The FDA has approved a supplemental license application for Gazyva in combination with chlorambucil chemotherapy in previously untreated chronic lymphocytic leukemia.
FDA has granted approval for Somatuline (lanreotide; Ipsen) injection 120 mg for gastroenteropancreatic neuroendocrine tumors.
The FDA has expanded the indication of Cyramza (ramucirumab) for the treatment of metastatic non-small cell lung cancer (NSCLC).
The FDA has approved Blincyto (blinatumomab; Amgen) for the treatment of acute lymphoblastic leukemia (B-cell ALL).
The FDA has approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer.
Lenvatinib has been submitted as a treatment for progressive radioiodine-refractory, differentiated thyroid cancer.
List of FDA-Approved medications used for the maintenance and treatment of chronic obstructive pulmonary disease (COPD).
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