The trial will assess the therapy against physicians’ choice of standard of care in individuals who have undergone previous systemic therapies. Credit: Volha\_R / Shutterstock.
Chinese biopharmaceutical company Yingli Pharma has obtained [US Food and Drug Administration (FDA) approval](https://www.prnewswire.com/news-releases/yingli-pharma-announces-successful-end-of-phase-2-meeting-with-fda-and-clearance-of-global-multi-center-phase-3-registration-study-design-of-linperlisib-for-the-treatment-of-relapsed-andor-refractory-peripheral-t-cell-lymphoma-302416397.html) for a Phase III trial of linperlisib for relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL).
The approval was given following a Type B End-of-Phase II meeting, in which Yingli Pharma discussed the drug’s overall development programme and regulatory path.
The global registration trial is due to begin in the second quarter of this year and will include enrolment from the US and other nations.
It will assess linperlisib against physicians’ choice of standard of care in individuals who have undergone previous systemic therapies.
Yingli Pharma CEO and chairman Michael Hui said: “This is a major milestone for linperlisib. We are very excited that linperlisib has entered the global pivotal study stage with the agreement from the FDA.
“We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development programme to bring more treatment options for patients with R/R PTCL.”
Yingli Pharma said linperlisib had shown a ‘well-tolerated’ safety profile in various haematologic and solid tumour trials.
In 2022, the therapy gained approval in China for R/R follicular lymphoma (FL) treatment, as well as orphan drug designation from the US FDA for FL, T-cell lymphoma, and chronic lymphocytic leukaemia/small lymphocytic lymphoma.
So far, more than 6,000 patients have been treated with linperlisib in clinical trials and after market approval, including more than 165 R/R PTCL patients across China, the US and Europe.
According to Yingli Pharma, these subjects have demonstrated a ‘consistent’ and ‘well-tolerated’ safety profile.
Linperlisib is Yingli Pharma’s first drug candidate and has received Breakthrough Therapy status from the NMPA in China.
This has made Yingli Pharma the second pharmaceutical company in China and the first based in Shanghai to receive this recognition.