The U.S. Food and Drug Administration has created several unique incentives for companies that develop treatments for rare or intractable diseases like malignant mesothelioma. These incentives, which include market exclusivity or expedited movement through the drug approval process, are offered in part because the audience for these drugs is so small that the drugs offer little hope for profit. Earlier this week, Targovax ASA, the company behind the promising virus-based cancer therapy ONCOS-102, announced that the drug has received Fast-Track designation for the treatment of malignant pleural mesothelioma based on encouraging results from recent studies.
Recent Study Reveals Extended Overall Survival With ONCOS-102/Chemotherapy Combination
The news of ONCOS-102 being fast-tracked by the FDA for the treatment of malignant pleural mesothelioma comes just two months after Targovax released an encouraging 18-month status update on patients treated with a combination of the virus-based cancer therapy and chemotherapy. Patients receiving the first-line protocol demonstrated a median overall survival of at least 18.2 months compared to 14.2 months for patients treated with chemotherapy alone.
Very few drugs have shown promise in the treatment of malignant mesothelioma, so this move by the FDA is seen as an extremely positive indication of their hopes for the treatment’s effectiveness. A Fast-Track designation is viewed as an endorsement and acknowledgement of a drug’s promise: it is reserved for therapies whose pre-clinical and clinical efficacy are seen as potentially addressing unmet medical needs in serious medical conditions. When a drug receives this designation, it creates an expedited regulatory review process and indicates a high likelihood of the drug receiving a shortened review time.
ONCOS-102 Had Previously Received Orphan Drug Designation
ONCOS-102 has been the source of excitement and enthusiasm among mesothelioma advocates and medical professionals for some time, and had previously received Orphan Drug Designation from both the U.S. agency and the European EMA, which is the equivalent for the European Union. Orphan Drug Designation provides a drug developer with market exclusivity for seven years in the United States and ten years in the EU.
Speaking of the new development, Targovax VP of Regulatory Affairs Dr. Ingunn Munch Lindvig said, “Securing this Fast-Track designation is a very important milestone for the ONCOS-102 program. Most importantly Fast-Track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need.”
If you or someone you love has been diagnosed with malignant mesothelioma, the news of this development is very encouraging. For more information on innovative treatments, contact the Patient Advocates at Mesothelioma.net today at 1-800-692-8608.FREE Mesothelioma Packet