FDA

FDA Approves Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

FDA Approves Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

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This latest approval now makes enzalutamide the only FDA-approved oral medication indicated for both metastatic and nonmetastatic castration-resistant prostate cancer.

FDA-Approved Breast Cancer Drug Treatments

Treatment chart with usual dosage, strength, and formulation of FDA approved medications for breast cancer.

FDA-Approved Colorectal Cancer Drug Treatments

Colorectal cancer treatment regimen chart.

FDA-Approved Non-Small Cell Lung Cancer (NSCLC) Drug Treatments

Non-small cell lung cancer (NSCLC) treatment regimen chart.

FDA-Approved Ovarian Cancer Drug Treatments

FDA-Approved treatment options for individuals with ovarian cancer including dosing.

FDA-Approved Prostate Cancer Drug Treatments

Approved prostate cancer drug treatments including formulations and usual dosing.

FDA's Accelerated Approval Pathway Needs Active Management

FDA's Accelerated Approval Pathway Needs Active Management

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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 <i>BRAF V600E, V600K</i> Mutation-Positive Melanoma

FDA Approves Encorafenib Plus Binimetinib for BRAF V600E, V600K Mutation-Positive Melanoma

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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

FDA Grants Priority Review to Dabrafenib and Trametinib Combination for Resected Melanoma

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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 Granted Priority Review for Castration-resistant Prostate Cancer

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Apalutamide is a next-generation, orally administered inhibitor of the androgen receptor.

FDA Approves Bosutinib for Newly Diagnosed Chronic Myeloid Leukemia

FDA Approves Bosutinib for Newly Diagnosed Chronic Myeloid Leukemia

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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.

Cabozantinib Approved as First-line Therapy for Advanced Renal Cell Carcinoma

Cabozantinib Approved as First-line Therapy for Advanced Renal Cell Carcinoma

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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 NSCLC

FDA Accepts Supplemental New Drug Application for Osimertinib as First-line Treatment in EGFR-mutant NSCLC

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Data from FLAURA may position osimertinib as the first-line standard of care for patients with EGFR-mutant NSCLC.

FDA Grants Breakthrough Therapy Designation to Adjuvant Dabrafenib Plus Trametinib for Melanoma

FDA Grants Breakthrough Therapy Designation to Adjuvant Dabrafenib Plus Trametinib for Melanoma

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Dabrafenib plus trametinib is the first adjuvant therapy indicated specifically for melanoma with the BRAFV600 mutation.

TPX-0005 Granted Orphan Drug Designation for Non-small Cell Lung Cancer

TPX-0005 Granted Orphan Drug Designation for Non-small Cell Lung Cancer

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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.

TESARO Completes Niraparib NDA for Recurrent Ovarian Cancer

TESARO Completes Niraparib NDA for Recurrent Ovarian Cancer

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The NDA is based on findings from the international, double-blind, phase 3 ENGOT-OV16/NOVA trial.

Enzalutamide Prescribing Info Updated To Include New TERRAIN Data

Enzalutamide Prescribing Info Updated To Include New TERRAIN Data

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The FDA has approved a sNDA to update the US prescribing information for Xtandi (enzalutamide) capsules.

FDA Approves Cabozantinib for Advanced Renal Cell Carcinoma

FDA Approves Cabozantinib for Advanced Renal Cell Carcinoma

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Cabozantinib (Cabometyx) has recieved FDA approval for treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.

FDA 2015 Drug Approvals Encompass Wide Range of Cancer Types

FDA 2015 Drug Approvals Encompass Wide Range of Cancer Types

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The year 2015 brought treatment advances for patients with myriad cancer types, as reflected in U.S. Food and Drug administration approvals.

2015 FDA Drug Approvals for Metastatic Lung Cancer Highlight Advances in Personalized Medicine

2015 FDA Drug Approvals for Metastatic Lung Cancer Highlight Advances in Personalized Medicine

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A comprehensive review of the 6 drugs approved for the treatment of patients with metastatic squamous and nonsquamous non-small cell lung cancer.

Alectinib Approved by FDA for Non-Small Cell Lung Cancer

Alectinib Approved by FDA for Non-Small Cell Lung Cancer

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The FDA has granted alectinib (ALECENSA) accelerated approval for the treatment of patients with non-small cell lung cancer.

FDA Approves Palbociclib for ER+, HER2- Advanced Breast Cancer

FDA Approves Palbociclib for ER+, HER2- Advanced Breast Cancer

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The FDA granted accelerated approval to Ibrance (palbociclib) for human epidermal growth factor receptor (HER2)-negative metastatic breast cancer.

FDA Approves Lynparza for Ovarian Cancer

FDA Approves Lynparza for Ovarian Cancer

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The FDA has granted approval to Lynparza for the treatment of BRCA mutated advanced ovarian cancer.

FDA Adds New Data to Gazyva Prescribing Information

FDA Adds New Data to Gazyva Prescribing Information

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The FDA has approved a supplemental license application for Gazyva in combination with chlorambucil chemotherapy in previously untreated chronic lymphocytic leukemia.

Somatuline Approved by FDA for Neuroendocrine Tumors

Somatuline Approved by FDA for Neuroendocrine Tumors

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FDA has granted approval for Somatuline (lanreotide; Ipsen) injection 120 mg for gastroenteropancreatic neuroendocrine tumors.

Cyramza Gains New Indication for Metastatic Lung Cancer (NSCLC)

Cyramza Gains New Indication for Metastatic Lung Cancer (NSCLC)

The FDA has expanded the indication of Cyramza (ramucirumab) for the treatment of metastatic non-small cell lung cancer (NSCLC).

First-in-Class Leukemia Drug Approved

First-in-Class Leukemia Drug Approved

The FDA has approved Blincyto (blinatumomab; Amgen) for the treatment of acute lymphoblastic leukemia (B-cell ALL).

Xtandi Approved for Metastatic Castration-Resistant Prostate Cancer

Xtandi Approved for Metastatic Castration-Resistant Prostate Cancer

The FDA has approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer.

Lenvatinib Submitted to FDA for Thyroid Cancer Approval

Lenvatinib Submitted to FDA for Thyroid Cancer Approval

Lenvatinib has been submitted as a treatment for progressive radioiodine-refractory, differentiated thyroid cancer.

FDA-Approved Chronic Obstructive Pulmonary Disease Treatment

List of FDA-Approved medications used for the maintenance and treatment of chronic obstructive pulmonary disease (COPD).

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