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Association details:
| Biomarker: | HER-2 exon 20 insertion |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | tuxobertinib (BDTX-189) (EGFR inhibitor, HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation
Published date:
07/28/2020
Excerpt:
...Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 (HER2) mutation or an epidermal growth factor receptor (EGFR) or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.
Source:
Title:
A Phase 1/2 Study to Assess the Safety and Antitumor Activity of BDTX-189 in Patients with Advanced Solid Malignancies
Excerpt:
...EGFR or HER2 exon 20 insertion mutation as determined by a validated next-generation sequencing (NGS) test routinely used by each institution using tissue and/or plasma. ...
Trial ID:
Source:
Title:
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
Excerpt:
...EGFR or HER2 exon 20 insertion mutation(s) 3....
Trial ID:
