Lenalidomide

In 2024, FDA approved several cancer treatments including Elahere for gynecologic cancers, Udenyca biosimilar for on-body administration, Onivyde for metastatic pancreatic cancer, Enhertu for HER2-positive solid tumors, and Darzalex Faspro for multiple myeloma, based on clinical trial results showing improved survival and response rates.

Adding Darzalex to VRd improved minimal-residual disease (MRD) responses and progression-free survival (PFS) in transplant-ineligible or -deferred newly diagnosed multiple myeloma patients, according to the phase 3 CEPHEUS trial. The overall MRD-negativity rate was 60.9% with Darzalex plus VRd versus 39.4% with VRd alone at 10^-5 sensitivity, and 46.2% versus 27.3% at 10^-6 sensitivity. The 54-month PFS rates were 68.1% and 49.5%, respectively, reducing the risk for disease progression or death by 43%. Darzalex also almost doubled the MRD-negative complete response rates sustained for more than 12, 24, and 36 months.

The AQUILA trial showed single-agent daratumumab delayed progression in high-risk smoldering multiple myeloma. Experts discuss its implications, noting it's a conversation starter, not a one-size-fits-all solution, emphasizing the need for individualized patient care and further research on long-term impacts.

Teva Pharmaceutical Industries, with a $19.81B market cap, navigates legal challenges and market dynamics. Recent $750M settlement and strong Q2 2024 performance, driven by Austedo and GX sales, suggest growth. Analysts project 4.6% revenue growth for Q2 2024, with EPS estimates at $2.49 (FY1) and $2.85 (FY2). Teva's focus on biosimilars and complex generics positions it for future growth, despite competitive and legal risks.

The inMIND trial showed Monjuvi + Rituxan + Revlimid improved progression-free survival (PFS) to 22.4 months vs. 13.9 months for placebo in R/R follicular lymphoma. Key secondary endpoints also favored the experimental arm. Monjuvi aims to become a new standard-of-care option, with potential competition from other therapies.

Isa-RVd (isatuximab-irfc, lenalidomide, bortezomib, dexamethasone) as induction for 18 weeks, followed by autologous stem cell transplant, significantly reduced disease progression or death risk vs RVd in transplant-eligible newly diagnosed multiple myeloma patients, according to GMMG-HD7 trial data. The progression-free survival benefit was observed in most subgroups except those with WHO performance status over grade 1, high-risk cytogenetics, or R-ISS stage III disease. Isa-RVd also demonstrated deeper MRD-negative responses post-transplant compared to RVd.

The USPTO's Drug Patent and Exclusivity Study contradicts I-MAK's claims of 'patent thickets' and 'evergreening,' finding I-MAK's patent numbers unreliable. The study supports evidence-based policymaking, emphasizing the unreliability of simple patent counts in assessing market exclusivity.

Real-world data on tafasitamab-cxix (Monjuvi) in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed PFS of 11.3 months and OS of 24.8 months, with an ORR of 73.5%. Factors like later-line use, advanced disease stage, higher comorbidity scores, and bulky disease increased progression risk. Tafasitamab's effectiveness was greatest in second-line therapy, with CR rates of 23.2% and PR rates of 50.3%.

Adding Darzalex to Velcade, Revlimid, and dexamethasone (VRd) improved treatment response and reduced residual cancer cells in newly diagnosed multiple myeloma patients ineligible for stem cell transplant, as shown in the phase 3 CEPHEUS trial. It increased MRD negativity rates and progression-free survival, supporting its use as a standard care option.