FDA Approval for New Mesothelioma Drugs
By Kathy Cooke. 5th October 2020
Currently around 40% of mesothelioma patients receive chemotherapy with Alimta to improve their chances of survival, although overall survival chances are generally poor. However, when Alimta was approved by The FDA in 2004, mesothelioma patients finally had viable treatment options. An electronic device called Tumour Treating Fields is the only other FDA approved treatment for mesothelioma.
Now a new drug combination for people with inoperable pleural mesothelioma marks the first new medication for mesothelioma approved by The FDA since that date 16 years ago.
Doctors hope the new drug combination - Nivolumab with Ipilimumab - will extend survival for more people.
The combination are immune checkpoint inhibitor drugs that complement each other. Nivolumab helps existing T-cells discover the mesothelioma tumours and Ipilimumab helps to activate and proliferate T-cells. Together they slow down the growth of mesothelioma tumours.
Nivolumab, the generic name for the trade drug name Opdivo®, is an immunotherapy drug used to treat different types of cancer including melanoma, metastatic non-small cell lung cancer, renal cell cancer and classical Hodgkin's lymphoma.
Was The Clinical trial of Ipilimumab and Nivolumab successful?
A recent clinical trial of more than 600 patients with inoperable malignant pleural mesothelioma lead to the FDA approval. The objective was to find out if the new drug combination improved overall survival compared to chemotherapy. The treatment was for 2 years unless there was an unacceptable level toxicity or until the mesothelioma progressed.
In the trial, the patients had infusions of Nivolumab every 2 weeks. Some of the patients also got Ipilimumab every 6 weeks for up to two years. Others had up to 6 cycles of chemotherapy.
The mesothelioma patients who received the Ipilimumab and Nivolumab combination lived for an average of just over 18 months. The patients who received chemotherapy with Nivolumab lived for just over 14 months. After a year most - almost 70% - of the patients who got the immunotherapy drug combination were still alive. This compared to 58% of chemotherapy patients.
The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Bristol-Myers-Squibb received FDA approval for the Ipilimumab / Nivolumab combination 5 months ahead of the predicted goal date.
“ Today’s approval of Nivolumab plus Ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma ”
said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
Are there adverse side effects from the mesothelioma drugs?
Yes, but they are relatively mild when compared to chemotherapy and can include coughs, diarrhea, nausea, fatigue, musculoskeletal pain, rashes and a decreased appetite. Ipilimumab can cause inflammation of healthy organs, such as the lungs, colon, liver and kidneys.
If you or a family member has been diagnosed with Mesothelioma and would like some advice, please call us on the number below and ask for Kathy Cooke or Warren Miller
1. FDA. 2 October 2020. FDA approves Nivolumab and Ipilimumab for unresectable malignant pleural mesothelioma.
2. The Lancet Respiratory Medicine. 1 March 2019. Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial.
3. Bristol Myers Squibb. 2 October 2020. U.S. Food and Drug Administration Approves nivolumab + ipilimumab as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
Kathy Cooke MA. BSc
Cancer consultant and advisor
Kathy has worked in the cancer field for over 30 years. She was course leader for the MSc in Radiotherapy and Oncology at University of Hertfordshire. Then pre-treatment radiotherapy manager at the Cromwell Hospital in London and Partnership Quality Lead for Macmillan Cancer Support.. Read more >