Bristol Myers Squibb’s Augtyro granted expanded FDA approval for solid tumours

14 Jun 2024
pmlive.com
Drug ApprovalClinical ResultImmunotherapyCell TherapyAcquisition
Bristol Myers Squibb’s Augtyro (repotrectinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat neurotrophic tyrosine receptor kinase (NTRK)-positive tumours.
Bristol Myers Squibbinhibitor (TKI) has been specifically authorised for use in adult and paediFood and Drug Administration (FDA)e and oldeneurotrophic tyrosine receptor kinase (NTRK)-positive tumoursere surgical resection is likely to result in severe morbidity, who have progressed following treatment or have no satisfactory alternative therapy.
Augtyro, which was added to BMS’ oncology portfolio in 2022 through its $4.1bn acquisition of Turning Point Therapeutics, was approved by the FDA tumoursvember to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Augtyro’s latest decision on the drug was supported by positive results from the phase 1/2 TRITurning Point Therapeuticsted Augtyro in adults FDAh NTRK-positive solid tumours.ROS1-positive non-small cell lung cancer (NSCLC)
At aFDAdian follow-up of 17.8 months, 58% of Augtyro-treated patients who had not previously received any TKI treatment had Augtyrormed objective rNTRK-positive solid tumoursNTRKnse rate. In TKI-pretreated patients, with a median follow-up of 20.1 months, the confirmed objective response rate was 50%.
After one year of Augtyro treatment, 83% of TAugtyroe responding patients and 42% of TKI-pretreated responding patients were still in response.
“NTRK fusion-positAugtyroours can present challenges in the clinical setting, which is why it is important that we have additional treatment options for these patients,” explained TRIDENT-1 global trial lead, Alexander Drilon, Memorial Sloan Kettering Cancer Center.
HNTRK fusion-positive tumoursNTRKntinued: “The FDA approval of [Augtyro] adds an important tool to our toolbox, offering oncologists a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumours for both TKI-naïve and TMemorial Sloan Kettering Cancer CenterCancer
The decision comes FDAt two weeks afAugtyro FDA approved BMS’ CAR T cell therapy Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory mantle NTRK fusion-positive solid tumoursNTRK lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
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