AZ’s Lynparza gets prostate cancer breakthrough status
pharmafile | January 28, 2016 | News story | Sales and Marketing | AstraZeneca, Breakthrough Therapy Designation, FDA, lynparza, olaparib, prostate cancer
AstraZeneca’s Lynparza has been granted breakthrough therapy designation by the FDA as a monotherapy for the treatment of a specific group of patients with gene mutated prostate cancer.
The status applies to people with BRCA1/2 or ATM gene mutated metastatic castration-resistant prostate cancer (mCRPC), who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).
Lynparza (olaparaib) is among the first of a class of therapies called PARP inhibitors, which exploit tumour DNA repair pathways to kill cancer cells while sparing healthy cells.
Breakthrough status is granted when clinical evidence suggests a drug may offer substantial improvement over existing treatments. In the case of Lynparza, Phase II trial data suggested that men with prostate cancer with defective DNA damage repair mechanisms responded to AZ’s drug. The designation means the FDA will review the drug faster than usual – within 60 days of receiving the data.
Antoine Yver, head of oncology, global medicines development at AstraZeneca, says: “More than 27,000 men died of prostate cancer last year in the US alone. The breakthrough therapy designation for Lynparza is encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic castration resistant prostate cancer. We will work closely with the FDA to introduce Lynparza as a new treatment option as soon as possible.”
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 just 10 months.
Lynparza has been approved by regulatory authorities in 40 countries to treat ovarian cancer, and AstraZeneca is testing the drug in other cancers, including Phase III studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers.
Joel Levy
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
