Lenalidomide

FDA approves Sanofi's Sarclisa (isatuximab) in combination with VRd for newly diagnosed multiple myeloma patients ineligible for stem cell transplant, based on Phase 3 IMRIOZ trial showing significant reduction in disease progression risk.

FDA approves Sanofi's Sarclisa for use with Velcade, Bristol Myers' Revlimid, and dexamethasone in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant.

FDA approves Sarclisa with Velcade, Revlimid, and dexamethasone for newly diagnosed, transplant-ineligible multiple myeloma patients, showing a 40% reduction in disease progression or death in the IMROZ phase 3 trial.

Starton Therapeutics successfully uses BD’s on-body injector to deliver STAR-LLD, a low-dose lenalidomide, with positive Phase Ib trial results in multiple myeloma patients. Plans for larger Phase II trials in CLL and multiple myeloma in 2025.

FDA approved ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma, showing a 59% risk reduction in disease progression or death vs standard care in the CARTITUDE-4 trial. Despite early OS concerns, cilta-cel's benefits outweigh risks, offering a treatment-free period post-administration. Accessibility and logistics remain challenges.

FDA approved ciltacabtagene autoleucel (Carvykti) for relapsed/refractory multiple myeloma patients, based on CARTITUDE-4 study showing 59% reduced risk of disease progression or death. Median PFS not reached with cilta-cel vs 11.8 months with standard care. Cilta-cel showed 75.9% 12-month PFS rate, 73.1% CR or better rate, and 84.6% ORR. Safety profile includes grade 3/4 toxicities and boxed warnings for CRS, ICANS, and secondary malignancies.

Bristol Myers Squibb's repotrectinib, a next-gen TKI, seeks EMA approval for treating ROS1-positive NSCLC and NTRK-positive solid tumors. Based on TRIDENT-1 and CARE studies, it showed robust responses. FDA approved it as Augtyro for NSCLC. BMY aims to diversify its portfolio amid generic competition, with Opdivo already approved for NSCLC and plans to acquire Mirati Therapeutics for $5.8B, adding Krazati to its oncology portfolio.

Indian pharma companies, facing US FDA scrutiny and competition, are intensifying R&D in complex drugs. Firms like Dr Reddy's and Cipla have launched generics of Revlimid, a high-margin multiple myeloma treatment, to maintain their US generics market edge.

The FDA approved Johnson & Johnson's Rybrevant, a bispecific antibody for treating a specific mutation in non-small cell lung cancer. Bispecific antibodies, targeting two proteins simultaneously, are emerging as a promising treatment for various cancers, including lymphoma, leukemia, and multiple myeloma, with several drugs in advanced clinical trials.

Multiple myeloma, a cancer affecting plasma cells, leads to bone destruction and marrow failure. Incidence is higher in men and those over 65. Advances in therapy, including immune modulators and proteasome inhibitors, have improved survival rates. Lenalidomide, approved for first-line treatment, shows significant efficacy but comes with risks like embryofetal toxicity and hematologic issues.