Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) receives FDA Breakthrough Therapy Designation for the treatment of extensive-stage small cell lung cancer.
RT’s Three Key Takeaways:
- FDA Breakthrough Designation for Trodelvy: Gilead’s Trodelvy receives Breakthrough Therapy Designation for treating extensive-stage small cell lung cancer (ES-SCLC) in patients whose disease has progressed after platinum-based chemotherapy.
- Promising Clinical Results: The designation is based on results from the global phase 2 TROPiCS-03 study, showing Trodelvy’s potential as a second-line treatment for ES-SCLC.
- Expanded Indication for Trodelvy: Already approved for metastatic breast cancer, Trodelvy’s breakthrough designation opens the door for its potential use in additional cancer types, including lung cancer.
Gilead Sciences Inc announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.
The Breakthrough Therapy Designation is based on results from the global phase 2 TROPiCS-03 study ES-SCLC cohort, which showed encouraging results with Trodelvy as a second-line treatment for ES-SCLC. As recently presented at the IASLC 2024 World Conference on Lung Cancer, Trodelvy demonstrated promising antitumor activity in both platinum-resistant and platinum-sensitive disease, and the safety profile was consistent with previous Trodelvy studies.
These data support further investigation of Trodelvy in ES-SCLC, and Gilead plans to initiate a phase 3 clinical trial in this patient population.
Lung cancer is the second most diagnosed cancer in the US and the leading cause of cancer-related deaths. Approximately 15% of lung cancer cases are SCLC, with nearly 70% of patients with SCLC diagnosed at extensive-stage, which occurs when the cancer has spread to both lungs or beyond the lungs to lymph nodes or other organs.
For people with ES-SCLC whose disease does not respond to current first-line standard of care (platinum-based chemotherapy or immunotherapy), the prognosis is often poor, and treatment options are limited. There is an urgent need for new and more effective approaches to care that can improve survival and slow the progression of the disease.
Expansion Beyond Breast Cancer
Breakthrough Therapy Designation is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy. This is the second Breakthrough Therapy Designation for Trodelvy.
Trodelvy is the first and only approved Trop-2-directed antibody-drug conjugate that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers. Across phase 3 trials, Gilead Sciences is exploring Trodelvy alone or in combination with other agents across diverse tumor types and stages of disease. This includes collaborations with partners in academia, industry, and the global cancer community.
Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
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