FDA Accepts Novartis BLA for Monoclonal Antibody in ESCC
Novartis submitted its application based on Phase 3 Rationale 302 trial data that found the antibody reduced the risk of death in patients by 30 percent.
Source: FDA Official
By - FDA recently accepted Novartis’ Biologics License Application for its anti-PD-1 immune monoclonal antibody, tislelizumab, to treat unresectable recurrent locally advanced metastatic esophageal squamous cell carcinoma (ESCC).
Tislelizumab is a humanized lgG3 anti-PD-1 checkpoint inhibitor developed both as a monotherapy treatment and in combination with other therapies.
Novartis based the Biologics License Application submission on data from the Phase 3 Rationale 302 trial, which found that tislelizumab reduced the risk of death in patients by 30 percent.
Additionally, the drug extended median overall survival by 2.3 months compared to chemotherapy in individuals with unresectable recurrent locally advanced or metastatic ESCC who received prior systemic therapy.
“This is an encouraging step forward in our mission to deliver transformative therapies for people living with cancer, and especially for people with esophageal cancer, an aggressive disease with limited treatment options,” Jeff Legos, executive vice president and global head of oncology & hematology development at Novartis, said in the announcement.
“We are advancing tislelizumab as a key cornerstone of our immunotherapy program and PD-1 backbone for combination therapy. We will work with regulatory authorities to ensure it is available for people with esophageal cancer as soon as possible,” Legos continued.
In June 2021, FDA approved Asieris Pharma’s oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC).
And the China National Medical Products Administration (NMPA) also approved tislelizumab for three indications, including to treat patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and to treat patients with classical Hodgkin’s lymphoma (cHL).
NMPA also approved the antibody for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy.
ESCC is the most common type of esophageal cancer globally and the sixth leading cause of cancer-related death worldwide.
Surgical resection, radiotherapy, and chemotherapy are the primary clinical treatments for esophageal cancer.
But most recently, targeted therapies have proven to play an important role in treating esophageal cancer. These therapies include cetuximab and bevacizumab, which target epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF), according to a 2020 Nature study.
