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AstraZeneca clears regulatory hurdles with 'Imfinzi' and 'Lynparza'

By Josh White

Date: Monday 20 Jan 2020

AstraZeneca clears regulatory hurdles with 'Imfinzi' and 'Lynparza'

(Sharecast News) - AstraZeneca announced on Monday that its 'Imfinzi' (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted orphan drug designation by the Food and Drug Administration (FDA) in the United States, for the treatment of hepatocellular carcinoma (HCC), which is the most common type of liver cancer.
The FTSE 100 company said the FDA grants orphan drug designation to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the country.

It said liver cancer is the third leading cause of cancer death worldwide, and for patients with unresectable or advanced disease, only 13% were alive five years after diagnosis.

"Many patients with liver cancer are diagnosed and treated only after the disease is advanced, and there is an urgent need for new effective and tolerable treatments," said AstraZeneca's executive vice-president of oncology research and development.

"We are eager to bring new potential options to these patients and look forward to the results of our ongoing phase 3 'HIMALAYA' trial later this year."

The firm said the phase 3 HIMALAYA trial is testing Imfinzi and the combination of Imfinzi with tremelimumab in patients with unresectable, advanced HCC, who had not been treated with prior systemic therapy and were not eligible for locoregional therapy.

It was the first trial to test dual immune checkpoint blockade in the first-line advanced HCC setting.

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

At the same time, AstraZeneca and its partner MSD announced that a supplemental new drug application for 'Lynparza' (olaparib) has been accepted and granted priority review in the US.

The application was for patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who had progressed following prior treatment with a new hormonal agent.

A Prescription Drug User Fee Act date was set down for the second quarter of 2020.

The company said the priority review by the FDA was based on results from the phase 3 'PROfound' trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.

"Results of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66% based on a hazard ratio of 0.34 compared to abiraterone or enzalutamide in patients with BRCA1/2 or ATM-mutated mCRPC, the primary endpoint of the trial," the board said in its statement.

"The trial also showed that Lynparza reduced the risk of disease progression or death by 51% based on a hazard ratio of 0.49 versus abiraterone or enzalutamide in the overall trial population of patients with HRR-mutated mCRPC.

"The safety and tolerability profile of Lynparza in the PROfound trial was in line with that observed in previous clinical trials."

At 0810 GMT, shares in AstraZeneca were down 0.06% at 7,873p.

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