The Food and Drug Administration (FDA) granted the novel drug, SLS009, a Fast Track Designation for the treatment of patients with relapsed or refractory peripheral T-cell lymphomas (PTCL), according to Sellas, the manufacturer of the drug.
Fast Track designations are granted to therapies that will fill an unmet need in treating serious conditions, according to the FDA’s website.
“The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” Dr. Angelos Stergiou, president and chief executive officer of Sellas, said in a company-issued press release.
PTCL is a rare and aggressive group of non-Hodgkin lymphoma, which is a cancer type that begins in the lymphatic system. According to the National Institutes of Health, common types of PTCLs include:
· Angioimmunoblastic T cell lymphoma (AITL)
· Mycosis fungoides (MF)
· Primary cutaneous anaplastic lymphoma (PCALCL)
· PTCL not otherwise specified
SLS009 works by inhibiting the CDK9 protein on cancer cells, which is involved in the development and progression of certain lymphomas. The drug showed promise in the dose-escalation portion of a phase 1 clinical trial with analyzed SLS009 in relapsed or refractory hematologic malignancies.
Study findings showed that some patients with acute myeloid leukemia and lymphoma experienced either complete or partial responses — disease completely disappears or shrinks, respectively.
Regarding patients with PTCL, four out of 11 (36.4%) experienced responses, including one patient who has been continuing treatment for more than 56 weeks. This is an improvement over the current standard of care for PTCL, Beleodaq (belinostat), which, according to a phase 2 trial, led to a 25.8% response rate in a similar patient population, according to the release.
“SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed dose-escalation portion of the phase 1 trial in relapsed/refractory hematological malignancies and with the Fast Track designation we are poised to accelerate its development,” Stergiou said in the release.
Now, the phase 1b/2 trial of SLS009 is ongoing in China. Researchers plan on enrolling up to 95 patients. Sellas is also pursuing a Breakthrough Therapy designation for SLS009, which would expedite the review and potential approval of the drug for this patient population. According to the release, Sellas and the FDA will meet in the fourth quarter of 2023 to discuss the indication.
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