The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Shots:The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutationsDesignation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…

ByRidhi Rastogi22 hours ago

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AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer

Shots: The CHMP’s positive opinion of Tagrisso + pemetrexed & Pt-based CT as a 1L treatment of locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC with exon 19 deletions or exon 21 (L858R) mutations was based on P-III (FLAURA2) study The P-III (FLAURA2) study assessed Tagrisso (80mg, oral, QD) + CT [pemetrexed…

ByDipanshu DixitJune 3, 2024

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CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC

Shots: The CHMP has granted positive opinion to Cejemly (sugemalimab) + CT as a 1L treatment of metastatic NSCLC The positive opinion was supported by the P-III (GEMSTONE-302) study, demonstrating improvement in PFS & OS with sugemalimab + CT vs PBO + CT among treatment-naïve stage IV NSCLC patients. Results were published in The…

ByDipanshu DixitJune 1, 2024

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BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Shots: The MAA was based on the evaluation of NSCLC patients (n=1,499) in 3 P-III studies incl. (RATIONALE 307) for Tevimbra + carboplatin + paclitaxel/nab-paclitaxel vs CT (1L treatment for sq. NSCLC), (RATIONALE 304) for Tevimbra + pemetrexed + platinum-containing CT vs CT (1L treatment for non-sq. NSCLC) & (RATIONALE 303) for Tevimbra vs CT…

ByDipanshu DixitFebruary 27, 2024

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer

CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC

BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer

CStone Pharmaceuticals’ Cejemly Receives the CHMP’s Positive Opinion for Treating NSCLC

BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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