Gilead's Trodelvy Receives FDA Breakthrough Therapy Designation for SCLC; Seladelpar Recommended for EU Approval
Key Insights
The FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for extensive-stage small cell lung cancer (search) (ES-SCLC) after platinum-based chemotherapy, based on promising results from the TROPiCS-03 study.
Gilead will collaborate with Terray Therapeutics (search) to discover and develop novel, small molecule therapies across multiple targets, leveraging Terray's tNova platform.
The European Medicines Agency's CHMP recommended approval of Gilead's seladelpar for primary biliary cholangitis (search) (PBC) in combination with UDCA or as monotherapy.
Gilead Sciences has achieved significant milestones with its breast cancer drug Trodelvy and its investigational drug seladelpar. The FDA has granted Breakthrough Therapy Designation to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (search) (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. This designation is based on data from the ES-SCLC cohort of the mid-stage TROPiCS-03 study, where Trodelvy demonstrated promising antitumor activity in both platinum-resistant and platinum-sensitive disease, with a safety profile consistent with previous studies. Gilead plans to initiate a phase III study in this patient population.
Trodelvy's Potential in SCLC
Small cell lung cancer (search) (SCLC) is an aggressive form of lung cancer, and the extensive-stage represents a significant challenge due to its rapid progression and limited treatment options after initial chemotherapy. Trodelvy's Breakthrough Therapy Designation highlights its potential to address this unmet need. The TROPiCS-03 study results suggest that Trodelvy could offer a new treatment option for patients who have progressed after platinum-based chemotherapy, regardless of platinum sensitivity.
Collaboration with Terray Therapeutics
Gilead also announced a strategic collaboration with Terray Therapeutics (search) to discover and develop novel, small molecule therapies across multiple targets. Terray will utilize its tNova platform to identify and develop small molecule compounds against targets selected by Gilead. Gilead will be responsible for further development and commercialization of any resulting products, should it exercise its option to exclusively license the compounds. Terray will receive an upfront payment and is eligible for milestone payments related to preclinical, clinical, and sales achievements, as well as tiered royalties on net sales of commercialized products.
Seladelpar's Path to EU Approval
In other regulatory news, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of seladelpar for the treatment of primary biliary cholangitis (search) (PBC). The CHMP's positive opinion supports the use of seladelpar in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. A final decision from the European Commission is expected in the first quarter of 2025. Seladelpar is already approved in the United States under the brand name Livdelzi.