Yescarta Second Line DLBCL
Yescarta Second Line DLBCL
On April 1, 2024, the US Food and Drug Administration (FDA) granted approval to Kite, a Gilead Sciences subsidiary, for Yescarta (Axicabtagene Ciloleucel), a CAR-T cell therapy, for the treatment of adult patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemotherapy immunotherapy or experience recurrence within 12 months of first-line chemotherapy immunotherapy. This approval marks a significant milestone in the fight against LBCL, offering a new and effective treatment option for patients in need.
Approval Date and Indication
Yescarta received FDA approval on April 1, 2024, as a second-line therapy for adult patients with relapsed or refractory large B-cell lymphoma (DLBCL) after first-line chemotherapy immunotherapy.
Yescarta Second Line DLBCL
Yescarta has demonstrated remarkable clinical efficacy in treating DLBCL. The approval was based on the results of the ZUMA-7 clinical study, which showed that Yescarta significantly prolonged event-free survival (EFS) by 6.3 months compared to the previous standard therapy. The two-year EFS rate was 2.5 times higher than that of the previous standard treatment.
2. ZUMA-7 Clinical Study:
The ZUMA-7 study was a global, randomized, open-label, phase 3 trial that compared Yescarta to the previous standard therapy in patients with relapsed or refractory LBCL within 12 months of first-line treatment. A total of 359 patients were enrolled at 77 centers worldwide and randomly assigned to receive either Yescarta or the previous standard therapy. Yescarta demonstrated a significant clinical advantage, with an improved EFS that was four times longer than the previous standard second-line treatment.
3. Safety Profile:
Yescarta’s safety profile was found to be manageable. The most common adverse reactions included cytokine release syndrome (CRS), neurological toxicities, and infection. However, these side effects were generally manageable with appropriate monitoring and treatment.
4. Impact on Treatment Paradigm:
The approval of Yescarta as a second-line therapy represents a significant shift in the treatment paradigm for DLBCL. This innovative CAR-T cell therapy offers a one-time infusion treatment, replacing the previous multi-step treatment approach. Moreover, Yescarta significantly improves patients’ quality of life compared to the previous standard therapy.
5. NCCN Recommendation:
In March 2022, the National Comprehensive Cancer Network (NCCN) included Yescarta in its first-line recommendation for the treatment of diffuse LBCL in patients with recurrence within 12 months or primary refractory disease. Yescarta became the first CAR-T cell therapy to receive a Category 1 recommendation for all types of cancer treatment by the NCCN.
6. Market Availability:
In China, Yescarta is known as “阿基仑赛” or “奕凯达” In June 2021, the National Medical Products Administration (NMPA) approved Yescarta for marketing in China, making it the first cell therapy product to receive approval in the country for the treatment of relapsed or refractory LBCL in adult patients after second-line or above systemic therapy.
Conclusion
Yescarta’s FDA approval as a second-line therapy for DLBCL represents a significant breakthrough in cancer treatment. Its exceptional clinical efficacy, manageable safety profile, and convenient one-time infusion administration make it a promising option for patients with relapsed or refractory LBCL. As a leading medical expert, I strongly recommend Yescarta for patients in need, as it offers a new hope for improving their outcomes and quality of life. For more information or to discuss treatment options, please do not hesitate to consult a healthcare professional.