There are hundreds of adult patients under the affliction of solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation. They could be progressing well with their prior treatment, but they do have access to satisfactory treatment options. This is according to Black Diamond Therapeutics Inc. (NASDAQ:BDTX), which has since received a fast track designation to BDTX-189 from the FDA.
The orally available, irreversible small molecule inhibitor, is the company’s lead product candidate. It is selectively designed to obstruct the activity of a wide range of previously unattended oncogenic driver mutations emanating from the ErbB kinases in EGFR and HER2.
There Is No Single Therapy with the Ability to Target the Wide Range of Mutations to Date
The mutations are predominantly spread across a broad range of cancers. This includes gastric, breast, bladder, colon, endometrial, and non–small cell lung cancer (NSCLC). Unfortunately, no single therapy is approved or available for use, which can attend to all these mutations.
Today, Kinase inhibitors are some of the common and targeted therapies, which have continued to transform the treatment of cancer. However, only a small number of patients with genetic profiles of metastatic cancer tumors have precision oncology medicine eligibility.
Thus, ‘’…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…,” the CEO and President of Black Diamond Therapeutics, David M. Epstein concluded.
The Potential for an Expedited Review of New Product Candidates
Having accomplished such a significant milestone, Black Diamond Therapeutics says it will be working closely with the FDA. The company will continue enrolling and dosing patients in the MasterKey-01 trial. This is the Phase 1/2 clinical study of BDTX-189 and will be assessing the safety, permissibility, pharmacokinetics, and anti-tumor activity of BDTX-189. The study also forms part of the company’s interests in discovering and developing tumor-agnostic therapies for hereditarily defined cancers.
It also presents an increasing need for an expedited review of new product candidates, which can promptly address life-threatening conditions.