[READ KEY TAKEAWAYS FROM THE CDDF WEBINAR]
The Cancer Drug Development Forum (CDDF) held a live webinar on the topic of regulatory considerations for Immunotherapy and Radiotherapy Combinations on Monday 27 February 2023. Here are the key takeaways from Prof Paz Vellanki (FDA)’s lecture and the discussion session moderated by Prof Ruth Plummer (CDDF) and Dr. Ricky Sharma (Varian).
1️⃣ Despite a strong scientific rationale for testing new combinations in clinical trials, there have been relatively few successfully licensed combinations of new drugs/biologics and radiotherapy so far.
2️⃣ The preclinical data package required by FDA for a combination of a new drug with radiotherapy requires safety data of the new drug, but not necessarily animal data of the combination with radiotherapy.
3️⃣ FDA Guidances exist for endpoints in clinical trials and for development of new drug-drug combinations. Discussion with the FDA is strongly advised when considering the overall drug development plans and potential regulatory pathway for novel immunotherapy-radiotherapy combinations.
4️⃣ Therapeutic radiation (e.g., external beam radiation, brachytherapy) is a device rather than a drug, but often investigated in combination with drugs/biologics. Radiopharmaceuticals (e.g., lutetium Lu-177 vipivotide tetraxetan) are considered drugs.
Click the following link to watch the key-takeaway video: https://lnkd.in/eEuzS66a