Alectinib

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.

Roche's OCREVUS Shows Strong Efficacy in MUSETTE Phase III Trial for Multiple Sclerosis

2 months ago

• Roche Holding's MUSETTE Phase III trial demonstrated strong efficacy of the approved 600 mg dose of OCREVUS for multiple sclerosis, reinforcing its position in the treatment landscape. • The company has launched a new subcutaneous formulation of OCREVUS, expanding administration options for patients while continuing to build its neuromuscular disease portfolio. • Roche has outperformed both the Swiss market and pharmaceutical industry with a 33.01% total shareholder return over the past year, bolstered by strategic collaborations and regulatory approvals.

Five-Year CROWN Trial Data Establishes Lorlatinib as First-line Standard for ALK+ NSCLC

3 months ago

• Extended follow-up data from the phase 3 CROWN trial demonstrates superior efficacy of lorlatinib over crizotinib, with median progression-free survival not yet reached at 60.2 months. • Strategic dosing approach starting at 50mg and gradually increasing to manage neurocognitive side effects is recommended, differing from the standard 100mg daily dosing in prescribing information. • Approximately 60% of patients may experience neurocognitive adverse events, requiring careful monitoring and proactive management through dose optimization.

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.

Durvalumab Gains Priority Review for Muscle-Invasive Bladder Cancer Treatment

6 months ago

• The FDA has granted priority review to durvalumab (Imfinzi) for muscle-invasive bladder cancer (MIBC), potentially expediting its approval. • Phase 3 NIAGARA trial data supports the application, showing a 32% reduction in disease progression or recurrence with perioperative durvalumab. • The Imfinzi regimen also demonstrated a 25% reduction in the risk of death, offering a significant survival benefit. • Regulatory decisions are anticipated in the second quarter of 2025, with potential implications for MIBC treatment standards.

Zongertinib Shows Promise in HER2-Mutated NSCLC, Gains Breakthrough Therapy Designation

6 months ago

• Zongertinib (BI 1810631) receives breakthrough therapy designation from the FDA and China for HER2-mutated NSCLC, potentially filling a critical treatment gap. • Phase 1b Beamion LUNG-1 trial data reveals a 66.7% objective response rate in previously treated patients with HER2-mutated NSCLC at the 120mg dosage. • The TKI demonstrates activity against brain metastases, with objective response rates of 33% (120 mg) and 40% (240 mg) in patients with asymptomatic brain metastases. • Zongertinib shows a favorable tolerability profile, with low rates of dose reduction and treatment discontinuation in clinical trials.

FDA Grants Accelerated Approval to Tarlatamab for Previously Treated Extensive-Stage Small Cell Lung Cancer

6 months ago

• Tarlatamab (Imdelltra) receives accelerated FDA approval for extensive-stage small cell lung cancer (SCLC) post-platinum-based chemotherapy. • The approval was based on the DeLLphi-301 study, which demonstrated a 40% objective response rate among evaluable patients. • The median duration of response in the study was 9.7 months, with a significant proportion of responses lasting over 6 months. • Common adverse events included cytokine-release syndrome, fatigue, and pyrexia, necessitating careful monitoring and management.

Lorlatinib Shows Promising Efficacy in ALK-Rearranged NSCLC with 21.8 Month Median PFS

4 years ago

• A real-world study of lorlatinib in ALK-rearranged non-small cell lung cancer demonstrated a median progression-free survival of 21.8 months, significantly higher than in previous trials. • The objective response rate was 43% with disease control achieved in 94% of patients, while 81% of patients with brain metastases showed objective response for intracranial lesions. • Patients experiencing adverse events, particularly hypercholesterolemia and edema, had significantly better outcomes than those without side effects, suggesting a potential correlation between drug exposure and efficacy.

Drug Development Updates