Skip to main content

FDA Approvals

Cabometyx Receives FDA Approval for Advanced Renal-Cell Carcinoma
FDA News & Updates, FDA Approvals
Web Exclusives
On April 25, 2016, the FDA approved cabozantinib (Cabometyx; Exelixis) for the treatment of patients with advanced renal-cell carcinoma (RCC) who had received anti-angiogenic therapy.  Read More ›
Approval of First Liquid Biopsy to Detect EGFR Mutations in Lung Cancer Can Improve Patient Outcomes
By Jessica Miller
Lung Cancer, FDA Approvals
TOP - August 2016, Vol 9, No 3
The first liquid biopsy used to detect gene mutations that are associated with non–small-cell lung cancer (NSCLC) was approved by the US Food and Drug Administration (FDA). Read More ›
A Pipeline Preview of 2016 FDA Approvals in Hematology/Oncology
By Ryan Beechinor, PharmD, BCPS, CPP; John M. Valgus, PharmD, MHA, BCOP
FDA Approvals
2016 First Annual Oncology Guide to New FDA Approvals
The year 2015 marked a noteworthy 12-month period for oncology drugs approved by the US Food and Drug Administration (FDA). The Center for Drug Evaluation and Research, which reviews the approval of antibodies and small molecules, approved a total of 45 new drugs in 2015; 15 of which are indicated for the treatment of cancer. Read More ›
Welcome to the First Annual Oncology Pharmacy Guide to New FDA Approvals
FDA Approvals
2016 First Annual Oncology Guide to New FDA Approvals
The Journal of Hematology Oncology Pharmacy has published its first annual Oncology Pharmacy Guide to New FDA Approvals with the goal of providing pharmacists and other healthcare stakeholders with a comprehensive review of pharmaceuticals that were newly approved, or that received important new indications, by the US Food and Drug Administration (FDA) in the previous year. The current 2016 edition represents the first year of publication of this Guide by the Journal of Hematology Oncology Pharmacy. Read More ›
FDA Approvals of Brand-Name Prescription Drugs in 2015
FDA News & Updates, FDA Approvals
2016 First Annual Oncology Guide to New FDA Approvals
The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories. Read More ›
New Oncology Drug Approvals in the US Outpace European Approvals
FDA Approvals
TOP - Daily

Patient access to oncology drugs is faster in the United States compared with Europe, according to a new study reported in the July/August Tufts Center for the Study of Drug Development (CSDD) Impact Report.

The study also found new oncology drug approvals between 2000 and 2011 were greater by 33% in the United States compared with Europe.

Read More ›
Bevacizumab Approval for Breast Cancer Revoked
FDA News & Updates, FDA Approvals
February 2012, Vol 5, No 1

The FDA revoked approval of the breast cancer indication for Avastin (bevacizumab; Genentech), ruling that the drug has not been proved to be safe and effective for that use. Bevacizumab remains on the market as approved for use for certain types of other cancers, including colon, kidney, lung, and brain (glioblastoma multiforme) cancer. Bevacizumab had received accelerated approval for the breast cancer indication in 2008; however, the FDA’s Oncologic Drugs Advisory Committee later recommended this approval be withdrawn. Read More ›

Oncology Drugs Pending FDA Approval in 2012
FDA Approvals
TOP - Daily

Roche’s vismodegib has received Priority Review status, with a confirmed action date of March 8, 2012. It is aimed at the treatment of advanced basal cell carcinoma (BCC). Vismodegib is an oral medicine designed to selectively reduce signaling in the Hedgehog pathway, which is associated with more than 90% of BCC cases.

Read More ›
ODAC Recommends FDA Withdraw Avastin’s Approval in Metastatic Breast Cancer
Breast Cancer, FDA Approvals
TOP - Daily

After 2 days of hearings, the Oncologic Drugs Advisory Committee (ODAC) confirmed the US Food and Drug Administration’s (FDA) earlier decision to remove bevacizumab’s (Avastin, Genentech) indication in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer.

 

Read More ›

Page 3 of 4