Ensartinib

2024 saw major lung cancer treatment advancements, including FDA approvals for ensartinib in ALK-positive NSCLC and tarlatamab for SCLC, alongside promising trial results for amivantamab and osimertinib, enhancing patient outcomes and survival rates.

December 2024 saw FDA approvals for several oncology treatments, including durvalumab for small cell lung cancer, zenocutuzumab-zbco for NRG1 fusion–positive NSCLC and pancreatic adenocarcinoma, and subcutaneous nivolumab for solid tumors. NCCN guidelines updated to include tumor-agnostic approvals. Tislelizumab plus chemo approved for PD-L1+ gastric/GEJ cancer, showing reduced death risk. Trastuzumab deruxtecan with pembrolizumab showed promising response rates in HER2-expressing or -mutant NSCLC.

In December 2024, FDA approved several treatments including zenocutuzumab for NRG1+ NSCLC and pancreatic cancer, cosibelimab for CSCC, and combinations for BRAF V600E+ mCRC. Fast track and breakthrough designations were granted for treatments in MDS, cervical cancer, NSCLC, and SCLC. Priority reviews were given for taletrectinib in ROS1+ NSCLC and remestemcel-L for pediatric acute GVHD.

In 2024, the FDA approved over 60 oncology therapies, including 11 first-in-class drugs. Highlights include Revumenib and Zolbetuximab for leukemia and gastric cancer, respectively, and new treatments targeting HER2, PD-L1, and ALK with improved efficacy and reduced toxicity. The approvals also featured novel strategies like bispecific antibodies and CAR T-cell therapies, alongside new indications for existing drugs.

The FDA made significant regulatory decisions, including the first drug approval for obstructive sleep apnea, a novel regenerative medicine for trauma patients, and treatments for rare diseases and cancer. Notable approvals include Eli Lilly’s Zepbound, Ionis Pharmaceuticals’ Tryngolza, and Humacyte’s Symvess. The FDA also expanded uses for existing drugs and issued rejections and warnings for others.

FDA approved treatments in December 2024 include durvalumab for small cell lung cancer, zenocutuzumab for NRG1+ NSCLC and pancreatic adenocarcinoma, cosibelimab for cutaneous squamous cell carcinoma, ensartinib for ALK+ NSCLC, encorafenib plus cetuximab for BRAF V600E+ metastatic colorectal cancer, tislelizumab plus chemo for PD-L1+ gastric/GEJ cancer, and subcutaneous nivolumab for advanced solid tumors.

FDA approved ensartinib for ALK-positive NSCLC patients on Dec 18, 2024. In trial eXALT3, ensartinib showed significant PFS improvement over crizotinib (HR 0.56), with median PFS of 25.8 vs 12.7 months. Common adverse reactions included rash, pain, constipation, and fatigue.

FDA approves encorafenib combo for BRAF V600E+ metastatic CRC, ensartinib for ALK+ NSCLC, issues CRL to subcutaneous amivantamab BLA in EGFR+ NSCLC, seeks EU approval for ibrutinib plus R-CHOP in frontline MCL, and grants breakthrough therapy designation to sacituzumab govitecan for second-line ES-SCLC.

Merck licenses a GLP-1 candidate from Hansoh Pharma; Astellas collaborates with Sangamo for gene therapy; Betta Pharma's Ensacove gains FDA approval for lung cancer; Mitsubishi Tanabe attracts buyout interest; BeiGene licenses a MAT2A inhibitor; Candid Therapeutics forms new collaborations; BMS regains China rights to a RayzeBio candidate.

FDA approved ensartinib for ALK-positive NSCLC patients on Dec 18, 2024. In trial eXALT3, ensartinib showed significant PFS improvement over crizotinib, with median PFS of 25.8 vs 12.7 months. Common adverse reactions included rash, pain, and fatigue. Recommended dose is 225 mg daily.