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FDA approves first treatment for advanced epithelioid sarcoma
Tazemetostat earns accelerated approval for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid...
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FDA approves pembrolizumab for BCG-unresponsive NMIBC with CIS
The checkpoint inhibitor is approved for patients who are ineligible for or have elected not to undergo cystectomy.
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FDA approves antibody-drug conjugate for advanced urothelial cancer
Enfortumab vedotin-ejfv was granted accelerated approval based on an overall response rate of 44%.
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FDA expands Xtandi approval to mCSPC
Enzalutamide was previously approved for castration-resistant prostate cancer.
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FDA approves atezolizumab combo as first line for advanced NSCLC
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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FDA issues warning for CDK 4/6 inhibitors
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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FDA approves darolutamide for nonmetastatic CRPC
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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FDA approves bevacizumab-bvzr for several cancers
The bevacizumab biosimilar is now approved for metastatic colorectal cancer, advanced non-squamous non–small cell lung cancer, recurrent...
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FDA approves pembrolizumab for advanced SCLC
The approval was based on an overall response rate of 19% in two nonrandomized trials.
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FDA approves trastuzumab-anns for HER2-positive breast, gastric cancer
This is the fifth FDA approval of a trastuzumab biosimilar.
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FDA approves NovoTTF-100L System for advanced mesothelioma
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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FDA approves T-DM1 as adjuvant treatment
The antibody-drug conjugate is approved for patients with HER2-positive early breast cancer who have residual invasive disease following...
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FDA approves pembrolizumab for first-line stage III NSCLC
Approval was based on improved overall survival for patients taking pembrolizumab, compared with those taking the investigators’ choice of...
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FDA approves palbociclib for men with HR+/HER2- advanced breast cancer
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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FDA approves cabozantinib for previously treated HCC
Approval was based on improvement in overall survival versus placebo in the phase 3 CELESTIAL trial.