Lenalidomide

MRD negativity maintained for at least 1 year after stopping lenalidomide maintenance in multiple myeloma patients, with 85% MRD-negativity rate at 12 months post-maintenance cessation.

Johnson & Johnson submitted an FDA application for Darzalex Faspro-based D-VRd regimen to treat newly diagnosed multiple myeloma patients ineligible for transplant, based on CEPHEUS study results showing 60.9% MRD-negativity and 43% risk reduction for progression or death.

Ciltacabtagene autoleucel (cilta-cel) reduced death risk by 45% in refractory myeloma patients compared to standard of care (SOC), with 30-month overall survival rates of 76.4% vs 63.8%. Cilta-cel also showed a 71% reduction in disease progression or death, with 30-month progression-free survival rates of 59.4% vs 25.7%. The therapy demonstrated deep responses and improved quality of life, though safety data remained consistent with previous reports.

MRD negativity maintained for 1 year post-lenalidomide cessation in multiple myeloma patients, with 85% MRD-negativity rate at 12 months. Study highlights feasibility of stopping maintenance therapy in patients with 3-year sustained MRD negativity, despite potential HRQOL impacts.

The 2024 International Myeloma Society Annual Meeting in Rio showcased advancements in multiple myeloma treatment, including promising results from trials like TRIMM-2, CEPHEUS, CARTITUDE-4, and RedirecTT-1, highlighting new therapies and improved outcomes for patients.

BMO Capital raised Bristol-Myers Squibb's price target to $53.00 from $48.00, maintaining a Market Perform rating, following the approval of COBENFY, priced at $1,850/30-day supply. Analysts project COBENFY could reach peak sales of $2.4 billion for Schizophrenia and $3.9 billion for Alzheimer's psychosis, reflecting a more optimistic outlook for the company's financial performance.

The phase 3 IFM2020-02 MIDAS study interim analysis showed that 6 cycles of isatuximab-irfc, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) induction therapy achieved a 95% overall response rate (ORR) in newly diagnosed multiple myeloma patients eligible for transplant, with 63% MRD negativity at 10-5 and 47% at 10-6. The study also demonstrated manageable safety and successful stem cell collection. The ongoing MIDAS trial is evaluating an MRD-adapted consolidation and maintenance strategy following Isa-KRd induction.

Bristol Myers Squibb receives FDA approval for Cobenfy, a new antipsychotic drug for schizophrenia, the first in decades. Cobenfy, also known as KarXT, lacks warnings about increased mortality in elderly patients and common side effects like weight gain and movement disorders. Bristol Myers expects $2.5 billion in U.S. sales by 2030 and plans to launch the drug at $1,850 a month. The approval is based on studies showing significant symptom reduction, targeting cholinergic receptors instead of dopamine. Cobenfy's side effects include vomiting and nausea, and it is not recommended for patients with urinary retention or severe kidney/liver disease.

The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.

Pharmaceutical companies have raised prices on over 1,000 drugs this year, disproportionately affecting Black and Latino patients aged 65 and over. Enhertu, used to treat HER2 negative breast cancer, has seen eight price hikes since 2019, reaching over $2,800 per month. Patients for Affordable Drugs calls the lack of affordability a 'crisis' disproportionately hurting people of color, who are more likely to suffer from chronic conditions requiring expensive drugs. Advocacy groups push for policies to lower drug prices, highlighting systemic racism in healthcare.