Roche's PD-L1 franchise player nabs priority review; One of world's first psychedelics research institutes opens in Australia
The FDA has just put Genentech’s latest shot at adding blockbuster sales for Tecentriq on the regulator’s inside track.
Roche said Tuesday that the agency has provided priority review status for a supplemental NDA to get the big PD-L1 franchise player approved for adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer.
Genentech researchers came up with the first evidence of disease-free survival for the drug following surgery and platinum-based chemotherapy. The drug reduced the risk of disease recurrence or death by 34%, making it a likely winner even before the Dec. 1 PDUFA date.
Peter Welford at Jefferies has been an enthusiastic supporter of the development team, holding out the prospect of additional sales in this setting of $1 billion-plus. He’s also noted, though, that physicians may still prove somewhat reluctant to use it without more data. — John Carroll
One of world’s first psychedelics research institutes opens in Australia
What’s being billed as the world’s first global research institute for psychedelics is launching in Melbourne, Australia.
With at least $29.5 million in funding over the next five years, the Psychae Institute will link leading researchers from several organizations around the world, including King’s College London, the University of Toronto, the University of Zurich, and the Federal University of Rio Grande in Brazil.
They will be joined by Australian institutions including Swinburne University, the University of Melbourne, Florey Institute of Neuroscience and Mental Health, Agriculture Victoria Research and NICM Health Research Institute (Sydney).
The non-profit institute was created to advance the study of psychedelics for mental health disorders and other conditions, including those that leverage psilocybin (the substance in “magic mushrooms”), MDMA, and products inspired by ayahuasca (a South American psychoactive plant medicine).
“It’s an exciting time for research into psychedelics, with a growing body of rigorous scientific evidence indicating that these substances may provide a potent new class of treatments for mental health disorders and possibly other medical conditions,” co-director Daniel Perkins said in a statement.
A handful of other institutes for psychedelics research exist around the world, including the Imperial Centre for Psychedelic Research, and the Johns Hopkins Center for Psychedelic and Consciousness Research. — Nicole DeFeudis
Agios’ old AML drug clears a registrational trial in China
Servier read out positive Phase III results yesterday showing that Agios’ old AML drug Tibsovo helped newly diagnosed patients live longer. Now, researchers are saying the drug also cleared a registrational study in China.
In a study run by C-Stone, Tibsovo met the pre-specified endpoints in Chinese patients with relapsed or refractory AML with a susceptible IDH1 mutation, the company said on Tuesday. While more detailed data are coming at a future conference, C-Stone said China’s National Medical Products Administration (NMPA) has accepted an NDA.
“In the field of AML treatment, we are facing urgent clinical treatment needs, especially for R/R AML patients with a susceptible IDH1 mutation, currently there is no targeted therapy available on the market in China,” principal investigator Wang Jianxiang said in a statement.
Agios won approval for Tibsovo in the US back in 2018 based on a single, single-armed trial — but European regulators wanted more data. C-Stone struck a licensing deal that same year for rights to the drug in Mainland China, Hong Kong, Macau and Taiwan. Then last year, Servier spent nearly $2 billion to acquire Tibsovo and the rest of Agios’ cancer pipeline.
On Monday, Servier said those who received Tibsovo and chemotherapy in a randomized Phase III trial lived longer than those who received a combination of placebo and chemotherapy. They also had higher response rates and complete remission rates. — Nicole DeFeudis
Belgium’s eTheRNA sets up Hong Kong subsidiary
In another sign of how big the Asia-Pacific market is looming, a Belgian biotech specializing in mRNA-based immunotherapies says it will set up a new subsidiary in Hong Kong.
Like the leaders in the field, eTheRNA says it’s pursuing both cancer and infectious disease applications.
eTheRNA Asia, as the subsidiary will be called, will focus on “supporting business and investor relations in China and especially the relationship between eTheRNA and its strategic partner, China Grand Pharmaceutical and Healthcare Holdings.” The duo had earlier created a joint venture named Nanjing AuroRNA. — Amber Tong