The drugmaker hopes to submit this data as part of a new drug application with the FDA later this year.
The program, called Project Facilitate, aims to help oncologists request access to investigational drugs but may only simplify part of the process.
This is the third drug the agency has approved with a pan-cancer indication.
The FDA center of excellence has engaged the technology vendor to incorporate real-world evidence into regulatory decision-making for precision oncology treatments.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The successful development of new targeted tissue-agnostic cancer drugs will be tied to the use of real-world data and new clinical trial formats.
The FDA and its pediatric oncology drugs advisory committee heard at a recent meeting how the drug is allowing some to live longer than expected, without toxicities.
Medicenna is hoping to discuss the data with the FDA and see if MDNA55 could be expedited to market for recurrent GBM patients overexpressing IL4.