BREAKING NEWS: FDA Approves Olaparib For Treatment of Advanced Prostate Cancer
This has been a truly historic week, with two new treatment options receiving FDA approval for men with advanced prostate cancer. Today, olaparib was approved by the FDA for certain metastatic prostate cancers that are not responsive to hormone therapy. Just last Friday, another drug in the class referred to as PARP inhibitors, rucaparib, was also approved.
For men with advanced disease, this is another modern weapon in the fight against advanced prostate cancer, a disease state that in the past had few treatment alternatives. For PCF science, these approvals are an important testament to the value of early foundational work which can bear multiple fruits in the form of new treatments, even many years later. Once again, PCF is proud to have been involved since the beginning, in every stage of the research that lead to this development.
Early data that PARP could be the key to finding treatments for prostate cancer came from a PCF-funded team led by Dr. Karen Knudsen of Thomas Jefferson University. PARP is a protein that is involved in repairing damaged DNA. Dr. Knudsen’s team proved that PARP is a driver of prostate cancer and that PARP inhibitors can suppress prostate tumor growth and progression.
Then in 2015, the PCF-SU2C International Prostate Cancer Dream Team published a landmark study demonstrating that about a third of mCRPC (metastatic castration-resistant prostate cancer) cases have mutations in certain genes, including about 13% of prostate cancer patients with a BRCA2 mutation (another DNA repair gene) in their tumor. This study was momentous, providing the motivation to test PARP inhibitors such as olaparib in prostate cancers.
The PCF Dream Team’s findings ignited a race among pharmaceutical companies to develop precision medications for prostate cancer. The PCF Team quickly initiated a Phase 2 clinical trial, which demonstrated that olaparib had anti-tumor activity in mCRPC patients with DDR (DNA Damage Repair) gene alterations. These findings resulted in olaparib receiving an accelerated FDA “Breakthrough Therapy Designation” in prostate cancer.
Olaparib is already FDA-approved for the treatment of other cancers, including breast and ovarian cancer. One of the benefits of olaparib is that it has fewer side effects than chemotherapy. This drug, a pill taken by mouth, is approved for patients whose prostate cancer has spread outside of the prostate and has developed resistance to hormone therapy, who also have certain mutations in DNA repair genes.
Today’s approval is based on results from a phase 3 clinical trial (PROfound) led by PCF-funded investigators Dr. Johann de Bono and Dr. Maha Hussain. These practice-changing findings were recently published in the prestigious journal The New England Journal of Medicine.
“This is tremendous news for men with mCRPC, their treatment team, and their families,” says PCF EVP and Chief Science Officer Dr. Howard Soule. “PCF has invested significantly over the past 10 years in the development of precision medicine approaches for prostate cancer patients, in which physicians select the best treatment, for each individual patient, at the precise time of need. As these approvals demonstrate time after time, early investment in innovative research continues to pay off.”
More information on this approval can be found here.