Drug Approval | November 08, 2025
Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
The discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons
The drug will target specific genetic mutations prevalent in certain types of cancers
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy
First and only PARP inhibitor to improve overall survival in early breast cancer
Imfinzi also recommended for patients with mismatch repair deficient disease
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