FDA Oncology Announcements

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4 Announcements

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer

Trial: AMPLITUDE
Drug: Akeega (niraparib and abiraterone acetate) · Multi-ingredient
Condition: Genitourinary

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

Trial: RAMP 201
Drug: Avmapki Fakzynja Co-pack (avutometinib and defactinib) · Multi-ingredient
Condition: Gynecologic

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer

Trial: MAGNITUDE
Drug: Akeega (niraparib and abiraterone acetate) · Multi-ingredient
Condition: Genitourinary

FDA approves Opdualag for unresectable or metastatic melanoma

Trial: RELATIVITY-047
Drug: Opdualag (nivolumab and relatlimab-rmbw) · Multi-ingredient
Condition: Dermatologic