The US Food and Drug Administration (FDA) has granted accelerated approval to Novartis’ combination therapy Tafinlar (dabrafenib) + Mekinist (trametinib) to treat solid tumours.
The combination therapy is indicated to treat unresectable or metastatic solid tumours with the BRAF V600E mutation in adult and paediatric patients aged six years and above whose disease progressed after prior treatment and have no alternative treatment options.
It can also help slow down the growth of the tumour by blocking the signals which are associated with the BRAF and MEK kinases that are implicated in the growth of various cancer types.
The regulatory has granted the approval under its Accelerated Approval Program, where the continued approval is subject to verification and description of clinical benefit in a confirmatory trial.
The drug combination is claimed to be the first and only BRAF/MEK inhibitor approved to treat solid tumours with the BRAF V600E mutation and is the only inhibitor for paediatric patients.
Novartis stated that the regulatory approval was supported by the clinical efficacy and safety data obtained from three clinical trials, including the Phase II Rare Oncology Agnostic Research (ROAR) basket study and the NCI-MATCH Subprotocol H study.
In the studies, the Tafinlar + Mekinist treatment resulted in up to 80% of overall response rates in BRAF V600E solid tumours patients.
The solid tumours include high- and low-grade glioma, biliary tract cancer and certain gynaecological and gastrointestinal cancers.
Furthermore, an additional study X2101 showed the combination therapy’s clinical benefit and acceptable safety profile in paediatric patients.
Novartis Oncology US head Reshema Kemps-Polanco said: “Tackling cancer is complex, which is why it is so important that we continue to follow the science as we pursue meaningful advances and new approaches to treating cancer.
“We are grateful to the patients, and to the multitude of individuals and teams working together to make this latest approval possible as we strive to do more for more people living with cancer.”