News
- Author:
- Laura Nikolaides
Publish date: January 24, 2020
Tazemetostat earns accelerated approval for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarco...
News
- Author:
- Laura Nikolaides
Publish date: January 8, 2020
The checkpoint inhibitor is approved for patients who are ineligible for or have elected not to undergo cystectomy.
News
- Author:
- Laura Nikolaides
Publish date: December 19, 2019
Enfortumab vedotin-ejfv was granted accelerated approval based on an overall response rate of 44%.
News
- Author:
- Laura Nikolaides
Publish date: December 17, 2019
Enzalutamide was previously approved for castration-resistant prostate cancer.
News
- Author:
- Laura Nikolaides
Publish date: December 4, 2019
The approval for first-line treatment was based on results of IMpower 130, which demonstrated an overall survival benefit with atezolizumab in comb...
News
- Author:
- Laura Nikolaides
Publish date: September 13, 2019
In a review of trials and postmarket safety databases, the FDA found there were reports of serious cases of pneumonitis, including fatalities, acro...
News
- Author:
- Laura Nikolaides
Publish date: July 31, 2019
The approval was based on improved metastasis free survival in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resista...
News
- Author:
- Laura Nikolaides
Publish date: June 28, 2019
The bevacizumab biosimilar is now approved for metastatic colorectal cancer, advanced non-squamous non–small cell lung cancer, recurrent glioblasto...
News
- Author:
- Laura Nikolaides
Publish date: June 18, 2019
The approval was based on an overall response rate of 19% in two nonrandomized trials.
News
- Author:
- Laura Nikolaides
Publish date: June 14, 2019
This is the fifth FDA approval of a trastuzumab biosimilar.
News
- Author:
- Laura Nikolaides
Publish date: May 24, 2019
The System delivers electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division and can be prescribed only by a healt...
News
- Author:
- Laura Nikolaides
Publish date: May 6, 2019
The antibody-drug conjugate is approved for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvan...
News
- Author:
- Laura Nikolaides
Publish date: April 12, 2019
Approval was based on improved overall survival for patients taking pembrolizumab, compared with those taking the investigators’ choice of chemothe...
News
- Author:
- Laura Nikolaides
Publish date: April 4, 2019
The FDA advises health care providers to tell male patients with female partners of reproductive potential to use effective contraception during tr...
News
- Author:
- Laura Nikolaides
Publish date: January 15, 2019
Approval was based on improvement in overall survival versus placebo in the phase 3 CELESTIAL trial.
