AZ’s Lynparza gains Breakthrough status in prostate cancer

AstraZeneca (AZ) has secured a valuable Breakthrough Therapy Designation for its cancer drug Lynparza, with the US FDA highlighting its potential to treat patients with a specific gene mutation.

Lynparza (olaparib) is the first PARP inhibitor to reach the market – a new class of drug that exploits tumour DNA repair pathway deficiencies to seek and destroy cancer cells.

The drug is already approved in the US and Europe to treat women with ovarian cancer who have the BRCA mutation, which is associated with an aggressive form of the disease.

An approval in prostate cancer, even against a targeted sub-population, would be a major expansion in Lynparza’s market.

The FDA has given the drug Breakthrough status for monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC). The drug would be used in patients who have already received a taxane-based chemotherapy and at least one newer hormonal agent, Janssen’s Zytiga (abiraterone) or Astellas’ Xtandi (enzalutamide).

The FDA’s decision was based on results of the TOPARP-A phase 2 trial, which showed that men with prostate cancer with defective DNA damage repair mechanisms responded to the drug.

The Breakthrough Therapy designation for Lynparza means the FDA will aim to reach a decision on the drug within 60 days of the company filing its data.

Once prostate cancer has progressed to mCPRPC, treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. Overall survival time for patients treated with chemotherapy and newer hormonal agents is 10 months. There are also no approved therapies for third-line and above mCRPC patients, and no targeted therapies are available for mCRPC patients with somatic or germline mutations in BRCA1, BRCA2 or ATM.

AZ is investigating olaparib in other PARP dependent tumours. Phase 3 studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers are underway, with further studies planned.

The Breakthrough approval is encouraging news for AZ, which is seeking to rebuild its business, with oncology as one of its main pillars.

The UK-headquartered firm is aiming to bring at least six new cancer medicines to patients by 2020.

Its oncology pipeline is focused on four disease areas – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates – with a strong focus on combinations.

The company also recently announced a $4 billion investment in Acerta Pharma, which brings with it a promising pipeline of BTK inhibitor treatments to its portfolio.

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