Blueprint Medicines will have to put down its pencil for now, pausing enrollment in a phase 1/2 trial of its solid tumor med BLU-222 so the FDA can take a closer look at visual adverse events.
The company did not disclose how many of the events occurred but said in an announcement Friday that all were grade 1 except for one grade 3 incident. The visual side effects consisted of light sensitivity and blurred vision. All events were resolved with “dose interruption or reduction,” and there have been no trial discontinuations due to the side effects, according to Blueprint.
The VELA trial launched in February 2022 to test doses of BLU-222 ranging from 50 mg up to 800 mg. Over 360 patients with solid tumors are expected to be recruited, with the grade 3 event seen in a patient who received a 600-mg dose.
The company is working with the FDA to investigate the side effects and will also amend the VELA trial protocol to provide better guidance to investigators, Chief Medical Officer Becker Hewes, M.D., said in a release. Blueprint still expects to report initial data from the trial in the first half of the year.