FDA accepts filing for Shorla Pharma's leukaemia treatment

The FDA has accepted a filing for oncology company Shorla Pharma’s T-cell leukaemia treatment, SH-111.

Shorla Pharma’s SH-111 treatment is being designed as an alternative therapy for T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). It will be targeted at paediatric patients over the age of one whose disease has not responded or has relapsed following at least two chemotherapy sessions.

T-cell leukaemia is a fast-progressing type of blood and bone marrow cancer which affects the lymphoid-cell-producing stem cells. It is the most common type of leukaemia that affects children, with around 85% of cases occurring in those younger than 15 years of age.

Treatments for T-cell leukaemia can often be in shortage, especially for patients who haven’t reached remission or have who relapsed during their treatment.

Speaking to EPM earlier in the year, Shorla Pharma’s CTO Orlaith Ryan described the company as one which concentrates “on indications where existing treatments are limited, in shortage or inadequate for the target population.”

The company currently has three treatments within its pipeline, including a therapy for treating breast and ovarian cancers and an oral solution that was developed to treat children with glioblastoma (SH-110) who have trouble swallowing.

“We’re very proud that SH-111 will have a significant clinical benefit particularly for children with leukaemia,” said Sharon Cunningham, CEO and co-founder of Shorla Pharma. “It’s a desperately needed product and a life-changing treatment that we are honoured to bring to patients in the United States, and later, worldwide.”

“Reaching this milestone is an important step as we continue to make progress across our growing pipeline. Our focus is on developing innovative oncology treatments for women and children, with a focus on rare cancers where existing treatments are limited, in short supply or inadequate,” Ryan added.