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AstraZeneca: FDA's ODD For Imfinzi, Tremelimumab; Priority Review For Lynparza

British drug major AstraZeneca (AZN,AZN.L) announced Monday that its Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation or ODD in the US. The approval is for the treatment of hepatocellular carcinoma or HCC, the most common type of liver cancer.

The US Food and Drug Administration grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

The company said the Phase III HIMALAYA trial is testing Imfinzi and the combination of Imfinzi plus tremelimumab in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy (treatment localised to the liver).

HIMALAYA is the first trial to test dual immune checkpoint blockade in the 1st-line advanced HCC setting. The results of the ongoing trial are expected later this year.

Imfinzi is not currently approved to treat HCC in any country, alone or in combination with tremelimumab.

Separately, AstraZeneca and Merck & Co., Inc. (MRK) announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US for HRR-mutated metastatic castration-resistant prostate cancer.

The Priority Review by the FDA is for patients with metastatic castration-resistant prostate cancer or mCRPC and deleterious or suspected deleterious germline or somatic homologous recombination repair or HRR gene mutations, who have progressed following prior treatment with a new hormonal agent.

A Prescription Drug User Fee Act or PDUFA date is set for the second quarter of 2020.

The Priority Review is based on results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.

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