Zidesamtinib

Nuvalent Advances Toward First NDA Submission with Pivotal Data Expected for ROS1 and ALK Inhibitors in 2025

14 days ago

• Nuvalent is preparing to submit its first New Drug Application by mid-2025 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC, with pivotal data expected in the first half of 2025. • The company plans to initiate the ALKAZAR Phase 3 trial in the first half of 2025, evaluating neladalkib versus alectinib for front-line treatment of ALK-positive NSCLC patients. • With $1.1 billion in cash reserves expected to fund operations into 2028, Nuvalent is transitioning toward becoming a fully integrated commercial-stage biopharmaceutical company.

Nuvalent's Lung Cancer Drug Shows Promise Amid Risks

4 months ago

Nuvalent, Inc., a clinical-stage biotechnology company, is making significant strides in the development of brain-penetrant tyrosine kinase inhibitors for non-small cell lung cancer (NSCLC). With promising early-stage clinical trial results for its lead candidates, zidesamtinib and NVL-655, and a strong financial foundation, Nuvalent is poised for potential commercialization. However, the company faces challenges in a competitive NSCLC treatment market and risks associated with clinical trial setbacks.

Non-Small Cell Lung Cancer Clinical Trial Pipeline Sees Significant Growth

4 months ago

The Non-Small Cell Lung Cancer (NSCLC) clinical trial pipeline is experiencing a boom with over 100 companies actively developing more than 120 therapies. Advances in targeted therapies, focusing on genetic mutations like EGFR, ALK, ROS1, BRAF, and MET, are improving treatment outcomes. Recent FDA designations and clinical trial initiations highlight the ongoing innovation and potential for new treatments in the NSCLC domain.

Nuvalent Fast-Tracks First Approval for Zidesamtinib in ROS1-Positive NSCLC by 2026

4 months ago

• Nuvalent aims for its first FDA approval by 2026, prioritizing zidesamtinib for TKI pre-treated ROS1-positive NSCLC patients. • NDA submission for zidesamtinib is expected by mid-2025, with topline pivotal data from the ARROS-1 trial anticipated in H1 2025. • Pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC from the ALKOVE-1 trial is expected by the end of 2025. • The company plans to initiate the ALKAZAR Phase 3 trial of neladalkib for TKI-naïve ALK-positive NSCLC patients in H1 2025.

Nuvalent Appoints Grant Bogle to Board of Directors, Strengthening Oncology Focus

5 months ago

• Nuvalent, a clinical-stage biopharmaceutical company, has appointed Grant Bogle to its Board of Directors to leverage his expertise in oncology and biotechnology. • Bogle's experience includes leadership roles at Epizyme, TESARO, and US Oncology, guiding numerous oncology products from development to commercialization. • Nuvalent anticipates pivotal data readouts in 2025 from trials of its kinase inhibitors and plans to initiate a Phase 3 trial for ALK-positive NSCLC. • Nuvalent is focused on developing precisely targeted therapies for cancer, aiming to overcome resistance and improve outcomes for patients with kinase-driven tumors.

Nuvalent's Zidesamtinib Shows Promise in ROS1-Positive NSCLC, Anticipates FDA Submission

6 months ago

• Nuvalent plans to release pivotal data from the Phase 1/2 ARROS-1 study of zidesamtinib in H1 2025 for advanced ROS1-positive NSCLC. • The company aims to submit a New Drug Application (NDA) for zidesamtinib in mid-2025, potentially securing its first FDA approval by 2026. • Early ARROS-1 data showed a 44% overall response rate in previously treated patients, with notable intracranial activity. • Nuvalent is in discussions with the FDA for a potential line-agnostic approval of zidesamtinib, supported by data from TKI-naïve patients.

Novel Drug Candidates Target Diverse Diseases: Malaria, Gastroparesis, and Cancer

8 months ago

• Novartis unveils NVP-FVP954, a fast-acting IV antimalarial for severe malaria, addressing the urgent need for new treatments due to rising resistance and high infection rates. • Altos Therapeutics and Takeda collaborate on TAK-906, a peripherally-restricted D2/D3 receptor antagonist, to treat gastroparesis by targeting the stomach and vomiting center. • Revolution Medicines advances RMC-9805, a covalent KRAS(G12D)(ON) molecular glue inhibitor, showing promise in synergizing with PD-1 inhibitors for cancer treatment.

ESMO 2024: AbbVie and Nuvalent Present Promising Data on Novel Cancer Therapies

8 months ago

• AbbVie presented data on mirvetuximab soravtansine for platinum-sensitive ovarian cancer, showing a 51.9% objective response rate in pre-treated patients. • Nuvalent's NVL-655 and zidesamtinib demonstrated durable responses in heavily pre-treated NSCLC patients, targeting ALK and ROS1, respectively. • AbbVie's telisotuzumab vedotin (Teliso-V) is under FDA review for accelerated approval in c-Met overexpressing non-small cell lung cancer. • Nuvalent plans to initiate a Phase 3 trial (ALKAZAR) of NVL-655 in TKI-naïve ALK-positive NSCLC patients in the first half of 2025.

Drug Development Updates