AstraZeneca and Daiichi Sankyo’s Enhertu has been recommended for approval in the European Union (EU) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). Specifically designed for tumors with an activating HER2 (ERBB2) mutation, the drug aims to fill a significant gap in systemic therapy options following platinum-based chemotherapy. Enhertu’s EU […]
Gilead Sciences, Inc. announced early data showcasing promising clinical activity of Trodelvy in combination with Merck’s KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer (NSCLC). The data was presented at the IASLC 2023 World Conference on Lung Cancer and focuses on patients without actionable genomic alterations. EVOKE-02 Preliminary Analysis: Notable Response Rates Across […]
The HERTHENA-Lung01 Phase 2 trial, presented at the 2023 World Conference on Lung Cancer by Daiichi Sankyo, demonstrated that Patritumab Deruxtecan has potential for treating EGFR-mutated metastatic non-small cell lung cancer (NSCLC). The drug revealed a confirmed objective response rate (ORR) of 29.8% in 225 patients, with a median progression-free survival of 5.5 months and […]
AI-driven precision medicine company Exscientia has initiated enrollment for its Phase 1/2 “ELUCIDATE” study, marking the first trial of its precision-designed CDK7 inhibitor, GTAEXS617 (‘617), in the treatment of advanced solid tumours. The trial aims to investigate the safety, efficacy, and pharmacokinetics of GTAEXS617 through multiple ascending doses for patients with advanced solid tumours, including […]
Eagle Pharmaceuticals has secured an additional indication for Pemfexy (pemetrexed injection) in the US, marking the fifth indication for the intravenous medication. Pemfexy in combination with Merck’s Keytruda and platinum chemotherapy has been now approved by the US Food and Drug Administration (FDA) for the initial treatment of patients with metastatic, non-squamous, non-small cell lung […]
Lantern Pharma said that the US Food and Drug Administration (FDA) has authorized it to move ahead with its Harmonic phase 2 clinical trial of LP-300, its investigational new drug in never smokers with non-small cell lung cancer (NSCLC). Harmonic will involve 90 patients in a multi-center, two arm, open-label, and randomized study for assessing […]
Bristol Myers Squibb (BMS) has agreed to acquire Turning Point Therapeutics, a clinical-stage precision oncology company based in California, for $4.1 billion. Listed on the Nasdaq, Turning Point Therapeutics is developing drug candidates that are said to target the highly common mutations related to oncogenesis. Its flagship asset is repotrectinib, which is a tyrosine kinase […]
American biopharma company Cullinan Oncology has agreed to sell its subsidiary Cullinan Pearl to Taiho Pharmaceutical, a Japanese specialty pharma company, for $275 million. Cullinan Oncology has also reached an agreement with Taiho Pharmaceutical to co-develop and co-commercialize CLN-081/TAS6417, the lead program of Cullinan Oncology. Cullinan Pearl holds worldwide rights to CLN-081/TAS6417 outside of Japan. […]
The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and Company (Lilly)’s sintilimab injection in nonsquamous non-small cell lung cancer (NSCLC). Lilly has been issued a complete response letter (CRL) for the BLA for the PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy. The US pharma […]
Genprex has dosed the first patient in the Acclaim-1 phase 1/2 clinical trial of REQORSA immunogene therapy candidate in combination with Tagrisso (osimertinib) in a certain patient population having late-stage non-small cell lung cancer (NSCLC). The combination of REQORSA and Tagrisso is being evaluated in the trial in late-stage NSCLC patients with activating epidermal growth […]