FDA Continues Approval of Immunotherapy Drugs Valuable In Mesothelioma Care

The U.S. Food and Drug Administration announced last month that it has granted Breakthrough Therapy Designation for the drug Imfinzi (durvalumab) in the treatment of non-small cell lung cancer. This approval brings one more immunotherapy option to lung cancer and mesothelioma patients, and another approval for AstraZeneca in its fight against cancer. This is the fourth Breakthrough Therapy Designation for AstraZeneca oncology medicine in three years.

AstraZeneca, an England-based pharmaceutical company, and MedImmune, its global biologics research and development arm, announced that Imfinzi targets patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. Instead of active monitoring following chemotherapy and radiation for these patients, Imfinzi could be used to prevent metastasis or the spread of cancer.

“For patients who have not progressed following chemoradiation therapy the only current option is active monitoring,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca in a July 31 press release announcing the approval. “Imfinzi is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, non-metastatic setting, so following Breakthrough Designation we hope to bring it to patients as soon as possible.”

Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s), as explained on the FDA’s website.

Durvalumab stimulates the patient’s immune system to attack the cancer and targets the cellular pathway known as PD-1/PD-L1 (proteins found in tumors that can evade detection by the immune system.) Durvalumab blocks the PD-L1 interaction with PD-1.

Keytruda, another immunotherapy drug targeting PD-L1, has brought new hope to the mesothelioma community with mesothelioma warriors showing excellent results from use of the drug. Mavis Nye of England, an eight-year mesothelioma survivor, can now claim remission from her pleural mesothelioma after participating in a two-year clinical trial of Keytruda. Now, she is giving back to the mesothelioma community through her newly formed Mavis Nye Foundation.

Oncologists and mesothelioma patients are buoyed by this recent approval. The same drug, also known as MEDI4736, is in several clinical trials for malignant pleural mesothelioma. The most recent clinical trial is a Phase II trial for 55 patients combining durvalumab with the standard chemotherapy duo of pemetrexed and cisplatin as first-line treatment. Pemetrexed is typically used in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma.

Also see “New Mesothelioma Clinical Trial is a Reminder That Trials Offer Latest Breakthroughs to Patients” for another durvalumab clinical trial for mesothelioma patients.

Malignant pleural mesothelioma is a cancer found in the outer lining of the lungs caused by inhaling asbestos fibers. Just as with NSCLC, there are a variety of treatments that can be prescribed to fight mesothelioma, but continued research is critically important for finding a treatment to extend survival. There is no cure for the asbestos-caused cancer.

Discuss all available mesothelioma treatment options with your doctor. To find out more about Imfinzi visit AstraZeneca.com.

https://www.astrazeneca-us.com/

Sources :

• Breakthrough Therapy Designation
  https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm
• AstraZeneca
  https://www.astrazeneca.com/our-company/media-centre/press-releases/2016/astrazeneca-reports-top-line-result-of-tremelimumab-monotherapy-trial-in-mesothelioma-29022016.html
• Global Medicines Development and Chief Medical Officer at AstraZeneca
  https://www.astrazeneca-us.com/media/press-releases/2017/imfinzi-durvalumab-granted-breakthrough-therapy-designation-by-us-fda-for-patients-with-locally-advanced-unresectable-non-small-cell-lung-cancer-07312017.html
• clinical trial of Keytruda
  https://clinicaltrials.gov/ct2/show/NCT01991938