The Food and Drug Administration has granted its Fast Track designation to Epstein-Barr Virus cytotoxic T lymphocytes (EBV-CTL) for the treatment of patients with rituximab-refractory, EBV-associated lymphoproliferative disease (EBV-LPD), a serious condition that can occur in patients who have had allogeneic hematopoietic cell transplantation, leading to life-threatening lymphomas and other cancers.
EBV-CTL is made from T-cells, collected from third-party and exposed to certain antigens, so that the activated T-cells can be used in an appropriate partially human leukocyte-antigen-matched patient with EBV-LPD. The activated EBV-CTL find cancer cells expressing EBV and kill them.
The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.
The Breakthrough Therapy designation for EBV-CTL, which is made by Atara Biotherapeutics, was based on data from two separate clinical trials.
The agency also granted Orphan Drug status to Reolysin for the treatment of patients with cancer of the fallopian tube. The drug is a proprietary isolate of the reovirus that infects and selectively targets tumors with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including EGFR, BRAF, KRAS, and others.
Reolysin, made by Oncolytics Biotech Inc., was recently also granted Orphan Drug status for the treatment of patients with ovarian cancers and patients with pancreatic cancers (http://bit.ly/1GJFXtD).
The Orphan Drug designation-to encourage development of drugs in the diagnosis, prevention, or treatment of a medical condition affecting fewer than 200,000 people in the U.S.-grants a product market exclusivity for a seven-year period if the sponsor complies with certain FDA specifications, as well as tax credits and prescription drug user fee waivers. The designation does not, though, shorten the duration of the regulatory review and approval process.
Reolysin's orphan drug status for cancer of the fallopian tube is based on data from a Phase 1/2 clinical trial of patients with metastatic ovarian, peritoneal, or fallopian cancers using concurrent intravenous and intraperitoneal administration of Reolysin-the same trial data that supported the drug's application for orphan drug status for ovarian cancers.
A second ongoing randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with Reolysin in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer completed enrollment in September.