Allos Therapeutics, Inc. today announced that the Journal of Clinical Oncology has published data from the Company’s pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN?® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
As assessed by the independent central review, of the 69 patients who did not have any evidence of response to their most recent prior therapy, 25 percent>2 once weekly by IV push over 3-5 minutes for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity.
The most common Grade 3-4 adverse events observed were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%). See below for Important Safety Information.
"As the only treatment approved for patients with relapsed or refractory peripheral T-cell lymphoma, FOLOTYN is an important addition to the treatment paradigm for this aggressive form of T-cell lymphoma," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "The strength of the results from the pivotal PROPEL study add to the growing body of data demonstrating that FOLOTYN is an effective treatment option for patients with relapsed or refractory peripheral T-cell lymphoma. As part of our ongoing commitment to the medical community and patients, we are exploring the potential of FOLOTYN as a single-agent and in combination with other therapies in a variety of hematologic malignancies, including first-line PTCL and relapsed or refractory cutaneous T-cell lymphoma."
Source: Allos Therapeutics, Inc.