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Keeping Track: Opdivo, Keytruda Continue Adjuvant Push As Cancer Dominates Recent Applications

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Data from a small Phase II study show that Aldeyra’s methotrexate formulation may address the underlying cause of 20%-30% of RP cases. The drug recently was denied US FDA approval in a rare ocular cancer.

Biomarker-Restricted Indication Urged For AstraZeneca’s Lynparza In First-Line Prostate Cancer

Eleven of 13 members of the Oncologic Drugs Advisory Committee favor limiting olaparib’s use with abiraterone in metastatic castration-resistant prostate cancer to patients with tumors that carry the BRCA mutation, a subgroup that represented only 11% of the patients in the PROpel study.

AstraZeneca’s Imfinzi Scores Neoadjuvant/Adjuvant NSCLC Two-fer At AACR

The PD-L1 inhibitor showed efficacy in the neoadjuvant/adjuvant setting, where Merck is developing Keytruda as well. BMS’s Opdivo was the first to win approval in neoadjuvant NSCLC.

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