Regulatory Novratis and BeiGene’s PD-1 drug falls victim to FDA...

Novratis and BeiGene’s PD-1 drug falls victim to FDA approval delay


Citing COVID-related restrictions on travel, the FDA has delayed the approval decision for Novratis and BeiGene’s tislelizumab. The inspections were supposed to take place in China.

According to a BeiGene representative, the company understands that usually when there is a delay, the problem is not with the data in the application package. A deferral and rejection are two different things, and historically the FDA has issued response letters when on-site inspections could not take place for some reason.

The representative stated that according to the FDA, the travel restrictions and the public health situation are being monitored and they are working on scheduling the due inspections as we speak. The decision was supposed to be made by Tuesday and no new tentative decision date has been given by the FDA as of now.

Commercial manufacturing of tislelizumab for China was started by BeiGene recently, at the new Guangzhou biologics site. The company also has a supply contract for the drug, with Boehringer Ingelheim.

The construction of a 42-acre biologics plant is underway in New Jersey. BeiGene’s new building is to be a manufacturing facility to produce tislelizumab for the United States market, while also having R&D capabilities. However, the phase 1 completion is anticipated to be in mid-2023.

In a prominent rejection in early 2022, Innovent Biologics and Eli Lilly’s Tyvyt (sintilimab) was criticized by the FDA for including a dated comparator therapy for newly diagnosed non-squamous non-small cell lung cancer application.

Later in April, Junshi Biosciences and Coherus Biosciences’ toripalimab got snubbed by the FDA in nasopharyngeal carcinoma. FDA requested the companies to make certain quality changes, following which they refiled, receiving a target action date for the last month of the year. However, these dates could be pushed on to the next year as the companies were warned that the travel restrictions could cause delays in the required on-site inspections in China.

Following these events, Tislelizumab is the newest PD-1 developed by China that has hit an obstacle on the road to reaching the United States. AN SVB Securities analyst stated the delay as a positive, basing his opinion on the aforementioned recent rejections. The analyst was of the view that delaying the review is much better than completely scrapping the review cycle.

PD-1s coming out of China are not the only ones facing a tough opponent in the FDA as Merck’s PD-1 Keytruda saw the doors closed after Agenus withdrew balstilimab in cervical cancer despite getting the go-ahead. Prior to that, MacroGenics and Incyte’s retifanlimab in anal cancer was given the red light by the FDA, asking for more data.

After the company’s own medicine did not do well in clinical trials, Novartis paid $650M to BeiGene for tislelizumab’s partial rights in key markets outside China. The company aims to build on possible combinations using tislelizumab with its own pipeline.

Novartis made it known that it intends to chase additional indications in non-small cell lung cancer and maybe nasopharyngeal carcinoma towards the end of the year. The companies have also informed of positive trial results in ESSC (esophageal squamous cell carcinoma).

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