Bayer’s BAY 2927088 Receives the USA FDA’s Break Through Designation for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
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- The BTD was granted based on the results from the P-I clinical trial evaluating the safety, efficacy & PK of BAY 2927088 in NSCLC patients (n=460, age ≥18yrs.) with HER2 mutations & who have received prior systemic therapy
- At the data cutoff of Aug 18, 2023, the results depicted an ORR of 26% with 1 CR, 13 PR & 1 unconfirmed PR whereas 29% of patients received SD & ORR was 60% in patients with HER2 exon 20 insertion mutant disease. The results from the trial were presented at ESMO 2023
- BAY 2927088 is an oral reversible TKI that functions by inhibiting the mutant HER2 incl. HER2 exon 20 insertions & HER2 point mutations & EGFR. The product was developed under the collaboration of Bayer & Broad Institute of MIT and Harvard
Ref: Bayer | Image: Bayer
Related News:- BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
