FDA grants fast track designation to BDTX-189 for solid tumors with certain mutations
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The FDA granted fast track designation to BDTX-189 for treatment of certain adults with solid tumors who progressed after prior therapy and have no satisfactory therapeutic treatment options.
The designation applies to use of BDTX-189 (Black Diamond Therapeutics) by patients whose tumors harbor allosteric HER2 mutations, or EGFR or HER2 exon 20 insertion mutations.
BDTX-189 — an oral, irreversible small molecule inhibitor — is designed to selectively inhibit the activity of a range of unaddressed oncogenic driver mutations of the ErbB kinases in EGFR and HER2.
“[Although] targeted therapies — such as kinase inhibitors — have transformed the treatment of cancer, only a small percentage of patients with metastatic cancer have tumors with genetic profiles that could make them eligible for an approved precision oncology medicine,” David M. Epstein, PhD, president and CEO of Black Diamond Therapeutics, said in a company-issued press release. “The FDA’s decision to grant fast track designation is an important recognition of BDTX-189’s potential to treat patients with currently unaddressed oncogenic mutations in EGFR and HER2.”
Enrollment continues for the phase 1/phase 2 MasterKey-01 trial, designed to assess the antitumor activity, safety, tolerability and pharmacokinetics of BDTX-189 for adults with advanced solid tumors for whom no standard therapy is available, or for whom standard therapy is intolerable or unsuitable.
The phase 1 portion of the trial is designed to determine the recommended phase 2 dose. It will include up to 88 patients with allosteric HER2 or HER3 mutations; EGFR or HER2 exon 20 insertion mutations; HER2-amplified or HER2-overexpressing tumors; or EGFR exon 19 deletion or L858R mutations.
The phase 2 portion is designed to evaluate antitumor activity and safety for adults with solid tumors that have an allosteric HER2 mutation or EGFR or HER2 exon 20 insertion mutations as determined by next-generation sequencing.
Phase 2 will include up to 100 patients in four cohorts: individuals with non-small cell lung cancer with EGFR or HER2 exon 20 insertion mutations; those with breast cancer with allosteric ErbB mutations; patients with solid tumors other than breast cancer who have S310F/Y mutations; and those with other tumors not included in the other three cohorts who harbor allosteric ErbB mutations.
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