The European Medicines Agency’s human medicines committee has recommended approval of a new tablet formulation of BeOne Medicines’ targeted blood cancer drug Brukinsa (zanubrutinib).
The company formerly known as BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended that the new formulation be approved for all indications covered by the original capsule version of its Bruton’s tyrosine kinase (BTK) inhibitor.
This includes certain cases of Waldenström’s macroglobulinaemia, marginal zone lymphoma, chronic lymphocytic leukaemia and follicular lymphoma.
The CHMP’s positive opinion was based on positive results from two phase 1 crossover studies of healthy adults, which demonstrated that Brukinsa tablets have the same efficacy and safety as Brukinsa capsules.
The new formulation will allow patients able to take two 160mg tablets a day rather than four of the current 80mg capsules, offering a simplified dosing experience. The tablets are also smaller and have a film coating, making them easier to swallow.
The European Commission will now review the CHMP’s recommendation as it makes a final decision on Brukinsa tablets, expected later this year.
Giancarlo Benelli, senior vice president and head of Europe at BeOne, said: “The CHMP’s positive opinion of our new tablet formulation of Brukinsa is an important step toward bringing this thoughtful, patient-centred innovation to people facing certain B-cell cancers across Europe.
“We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.”
The recommendation comes less than two months after BeOne’s Tevimbra (tislelizumab) was approved by the EC in combination with etoposide and platinum chemotherapy to treat adults with extensive-stage small cell lung cancer, an aggressive form of lung cancer, in the first line.
Tevimbra was also approved by the EC in November alongside platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy for those with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma.