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The FDA offers researchers new guidance to help keep trials on track.
Approval was based on a study showing combination treatment reduced disease progression or death by 40%.
The efficacy of Nerlynx with capecitabine was investigated in a randomized, multicenter, open-label clinical trial in 621 people.
This approval highlights a trend in cancer research, with drugs being designed for small, genetically defined populations of patients.
Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.
Clinical trials showed a high response rate, with almost 85% of participants experiencing tumor shrinkage with this targeted drug.
In a clinical trial, 46% of responding participants experienced a complete response lasting at least 12 months.
PARP inhibitor delays disease progression when used after successful chemotherapy.
60% of women treated with the antibody-drug conjugate experienced complete or partial tumor shrinkage.
Novel antibody-drug conjugate shrank tumors in more than 40% of people previously treated with immunotherapy.
The drug was previously approved for castration-resistant prostate cancer.
New site-agnostic therapies highlight the importance of genetic testing.
Even some of the newest, most expensive brand-name medicines have been plagued by quality and safety concerns during production.
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