US FDA approves three different oncology drugs in 1 week

In the last week, the US FDA has granted approval/accelerated approval to three different oncology drugs, each from different drugmakers with different indications. 

AstraZeneca 

The US FDA has granted approval to AstraZeneca’s Tagrisso in combination with chemotherapy for the treatment of stage 3 EGFR-mutated non-small cell lung cancer (NSCLC). Tagrisso acts a targeted tyrosine kinase inhibitor, and has demonstrated a significant reduction in the risk of disease progression or death. For EGFR-mutated NSCLC, Tagrisso is currently the only targeted therapy to improve patient outcomes in both early- and late-stage disease.  The FDA’s approval came based on trials that extended progression-free survival of a median of 9 years. 

Executive Vice President of the Oncology Business Unit at AstraZeneca Dave Fredrickson stated in a press release: “This important new treatment option can delay disease progression by nearly 9 additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the 1st-line advanced setting. This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.” 

While the clinical data for Tagrisso’s efficacy in reducing disease progression still requires maturation, a global study to assess Tagrisso’s efficacy and safety in combination with chemoradiation for stage III unresectable NSCLC in a phase III trial is estimated to be fully complete by 2026.  

Iovance Biotherapeutics 

Iovance Biotherapeutics was also granted accelerated approval by the US FDA for a cell therapy treatment for advanced melanoma, the first of its kind to be approved for the indication and for a solid tumour cancer.  

AMTAGVI, a suspension for intravenous infusion, is a T cell immunotherapy for adult patients presenting with unresectable/metastatic melanoma that has been previously treated with a PD-1 blocking antibody. With accelerated approval based on the overall response rate and duration of response, AMTAGVI is currently undergoin phase III trials to confirm clinical significance. 

Samantha R. Guild, President, AIM at the Melanoma Foundation, commented in a press release: “The approval of AMTAGVI offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients... This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.” 

Johnson & Johnson 

A bi-weekly treatment for those presenting with relapsed or refractory multiple myeloma has also been granted approval by the US FDA. TECVAYLI was granted FDA approval of the supplemental Biologics License Application at a reduced dosing frequency of 1.5 mg/kg every 2 weeks.  

TECVAYLI is the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, activating an immune response. In October 2022, TECVAYLI was approved for the treatment of adult patients with relapse/refractory multiple myeloma that had already received at least four lines of therapy.  

Rachel Kobos, VP, Oncology Research & Development at Johnson & Johnson, stated in a press release: “TECVAYLI is the only BCMA-targeted immune-based therapy with weight-based dosing. Today’s approval of bi-weekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules... As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.” 

Sources 

[1] Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer [Accessed February 22, 2024] https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-plus-chemo-approved-in-us-for-lung-cancer.html 

[2] Iovance’s AMTAGVI (Iifileucel) receives US FDA Accelerated Approval for Advanced Melanoma [Accessed February 22, 2024] https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvitm-lifileucel-receives-us-fda-accelerated 

[3] TECVAYLI (teclistamab-cqyv) biweekly dosing approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma [Accessed February 22, 2024] https://investor.jnj.com/files/doc_news/2024/Feb/20/tecvayli-biweekly-dosing-fda-approval-press-release_final.pdf