Ensartinib

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.

FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions

6 months ago

• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity. • Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors. • Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors. • Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.

Ensartinib Approved by FDA for First-Line ALK-Positive Non-Small Cell Lung Cancer

6 months ago

• The FDA has approved ensartinib (Ensacove) for first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). • Ensartinib demonstrated statistically significant improvement in progression-free survival compared to crizotinib in the eXALT3 trial. • Common adverse reactions to ensartinib include rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue. • The recommended dose of ensartinib is 225 mg orally once daily until disease progression or unacceptable toxicity.

Key Oncology Updates: Approvals, Designations, and Trial Results

6 months ago

• Treosulfan gains FDA approval for allogeneic hematopoietic stem cell transplantation conditioning in AML and MDS, offering a new option for adult and pediatric patients. • The FDA grants priority review to RP1 plus nivolumab for advanced melanoma after PD-1 inhibitor failure, with a decision expected by July 2025. • Dato-DXd receives breakthrough therapy designation from the FDA for pretreated EGFR-mutated NSCLC, based on promising phase 2 and 3 trial data.

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.

FDA Approves Bizengri for NRG1 Fusion-Positive Lung and Pancreatic Cancers

7 months ago

• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma and non-small cell lung cancer with NRG1 gene fusions. • Bizengri is the first systemic therapy approved by the FDA specifically targeting NRG1 gene fusions in these cancers after prior systemic therapy. • Clinical trial data showed overall response rates of 40% in pancreatic cancer and 33% in NSCLC, with manageable side effects, supporting the approval. • This approval highlights the importance of biomarker testing to identify NRG1 fusions, enabling personalized treatment for these difficult-to-treat cancers.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Oncology Drug Development Pipeline Remains Robust, Driven by Novel Therapies and Cell Therapies

7 months ago

• The oncology drug pipeline remains dominant, featuring approximately 1,600 medicines and vaccines, with a significant portion targeting rare cancers and solid tumors. • Global spending on cancer drugs is projected to reach $409 billion by 2028, driven by the high cost of novel agents, averaging over $200,000 per year. • Cell therapies for solid tumors are gaining traction, with 44% of all trials initiated in 2023 focusing on solid tumor indications, marking a significant trend in oncology. • Recent FDA approvals include targeted therapies like inavolisib for HER2-negative breast cancer and repotrectinib for NTRK-positive solid tumors, alongside immunotherapies and bispecific antibodies.

Brazil and Turkey Emerge as Key Clinical Trial Hubs for Cancer Drugs

8 months ago

• Brazil and Turkey are becoming increasingly attractive locations for pharmaceutical companies to conduct clinical trials due to lower costs and streamlined regulatory processes. • Regulatory agencies in both countries, such as ANVISA in Brazil and TITCK in Turkey, have implemented reforms to accelerate clinical trial approvals. • Major pharmaceutical companies like AstraZeneca, Merck, and Novartis are actively conducting Phase 3 cancer drug trials in these regions. • Collaborations between pharmaceutical firms, local hospitals, and contract research organizations (CROs) are enhancing the efficiency and quality of clinical trials.

Drug Development Updates