BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC).

The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.

Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases.

More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.

BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours.

The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its efficacy and safety with investigator’s choice of chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC.

The study demonstrated a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy, meeting its primary endpoint, and also showed a favourable safety profile for Tevimbra.

Mark Lanasa, chief medical officer, solid tumours at BeiGene, said the approval “represents a significant step in [the company’s] commitment to bringing [Tevimbra] to more patients around the world”.

Tevimbra will be available in the US in the second half of this year, according to BeiGene.

The FDA is also reviewing an application for use of the therapy as a first-line treatment in patients with unresectable, recurrent, locally advanced or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma.

The latest approval comes just one week after the US regulator approved BeiGene’s Brukinsa (zanubrutinib) to treat relapsed or refractory follicular lymphoma, the second most common type of non-Hodgkin lymphoma.

The BTK inhibitor was specifically authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy.

https://pmlive.com/pharma_news/beigenes-tevimbra-receives-fda-approval-to-treat-advanced-oesophageal-cancer/