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Laura Nikolaides

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FDA approves first treatment for advanced epithelioid sarcoma

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...

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News

FDA approves pembrolizumab for BCG-unresponsive NMIBC with CIS

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.

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News

FDA approves antibody-drug conjugate for advanced urothelial cancer

Author:
Laura Nikolaides
Publish date: December 19, 2019

Enfortumab vedotin-ejfv was granted accelerated approval based on an overall response rate of 44%.

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News

FDA expands Xtandi approval to mCSPC

Author:
Laura Nikolaides
Publish date: December 17, 2019

Enzalutamide was previously approved for castration-resistant prostate cancer.

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News

FDA approves atezolizumab combo as first line for advanced NSCLC

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...

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News

FDA issues warning for CDK 4/6 inhibitors

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,...

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News

FDA approves darolutamide for nonmetastatic CRPC

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-...

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News

FDA approves bevacizumab-bvzr for several cancers

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...

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News

FDA approves pembrolizumab for advanced SCLC

Author:
Laura Nikolaides
Publish date: June 18, 2019

The approval was based on an overall response rate of 19% in two nonrandomized trials.

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News

FDA approves trastuzumab-anns for HER2-positive breast, gastric cancer

Author:
Laura Nikolaides
Publish date: June 14, 2019

This is the fifth FDA approval of a trastuzumab biosimilar.

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News

FDA approves NovoTTF-100L System for advanced mesothelioma

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...

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News

FDA approves T-DM1 as adjuvant treatment

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...

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News

FDA approves pembrolizumab for first-line stage III NSCLC

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...

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News

FDA approves palbociclib for men with HR+/HER2- advanced breast cancer

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...

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News

FDA approves cabozantinib for previously treated HCC

Author:
Laura Nikolaides
Publish date: January 15, 2019

Approval was based on improvement in overall survival versus placebo in the phase 3 CELESTIAL trial.

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