Proparacaine

DARZALEX® Subcutaneous Regimen Receives CHMP Backing for Newly Diagnosed Multiple Myeloma Treatment

3 months ago

• Johnson & Johnson's DARZALEX® subcutaneous formulation combined with VRd receives positive CHMP recommendation for treating newly diagnosed multiple myeloma patients, regardless of transplant eligibility. • The recommendation is supported by the Phase 3 CEPHEUS study, which evaluated the efficacy of daratumumab-VRd compared to VRd alone in 395 patients with newly diagnosed multiple myeloma. • DARZALEX® has demonstrated significant impact in multiple myeloma treatment, having been used in over 618,000 patients worldwide and currently approved in eight indications.

FDA Approves Brentuximab Vedotin Combination for Relapsed/Refractory Large B-Cell Lymphoma

4 months ago

• The FDA has approved brentuximab vedotin in combination with lenalidomide and rituximab for adult patients with relapsed or refractory LBCL. • The approval is specifically for those ineligible for auto-HSCT or CAR T-cell therapy after two or more lines of systemic therapy. • Data from the ECHELON-3 trial demonstrated a statistically significant improvement in overall survival with the brentuximab vedotin combination. • Common adverse events included neutropenia, thrombocytopenia, anemia, and peripheral neuropathy, manageable with dose modifications.

FDA Grants Orphan Drug Designation to Rigel's R289 for Myelodysplastic Syndromes

4 months ago

• The FDA has granted Orphan Drug designation to R289 for treating myelodysplastic syndromes (MDS), offering incentives for its development. • R289, a dual inhibitor of IRAK1 and IRAK4, is currently in a Phase 1b study for lower-risk MDS patients who have relapsed or are refractory to prior treatments. • The Orphan Drug designation provides Rigel with potential tax credits, exemptions from certain FDA fees, and seven years of market exclusivity upon drug approval. • R289 had previously received Fast Track designation from the FDA for transfusion-dependent lower-risk MDS, highlighting its potential as a new treatment option.

Sarclisa (Isatuximab) Shows Promise in Multiple Myeloma Treatment: China Approval and Subcutaneous Formulation Advances

4 months ago

• China's NMPA has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone for relapsed/refractory multiple myeloma, marking a significant milestone for Sanofi. • A Phase 3 IRAKLIA trial demonstrated that subcutaneous isatuximab, delivered via an on-body system, achieved non-inferior objective response rates compared to intravenous administration. • Regulatory submissions for subcutaneous isatuximab are planned in the US and EU in the first half of 2025, potentially offering a more convenient administration option for patients.

Luspatercept Plus Lenalidomide Shows Promise in Non-del(5q) Myelodysplastic Syndrome

5 months ago

• A phase 1b trial combining luspatercept and lenalidomide demonstrates safety and preliminary efficacy in patients with non-del(5q) myelodysplastic syndrome (MDS). • The combination therapy showed a 50% hematologic improvement rate among evaluable patients, with notable red blood cell transfusion independence. • The study established a recommended phase 2 dose (RP2D) of lenalidomide at 10 mg daily and luspatercept at 1.0 mg/kg every 21 days. • These findings support further investigation of this combination to improve outcomes for lower-risk MDS patients lacking the del(5q) abnormality.

Leading MDS Expert Dr. Garcia-Manero Reflects on 25 Years of Mentorship and Innovation at MD Anderson

5 months ago

• Dr. Guillermo Garcia-Manero has led groundbreaking research in myelodysplastic syndromes (MDS) at MD Anderson Cancer Center, helping develop standard-of-care treatments including azacitidine and decitabine. • As fellowship program director in the Department of Leukemia, Dr. Garcia-Manero has mentored over 250 fellows over 25 years, creating a lasting impact on the next generation of hematology-oncology specialists. • Under his leadership, MD Anderson's MDS program has made significant advances in understanding disease biology and developing new targeted therapies, particularly benefiting older patients with complex comorbidities.

Incyte's Retifanlimab Shows Positive Phase 3 Results in Non-Small Cell Lung Cancer

6 months ago

• Incyte's Phase 3 POD1UM-304 trial showed retifanlimab plus chemotherapy significantly improved overall survival in NSCLC patients. • The combination therapy resulted in a median overall survival of 18.1 months compared to 13.4 months with chemotherapy alone. • The study also met secondary endpoints, including progression-free survival, overall response rate, and duration of response. • Incyte plans to submit a supplemental Biologics License Application to the FDA in 2025.

BTK Inhibitors Reshape Treatment Landscape for Lymphomas: Expert Insights

6 months ago

• Experts highlight the evolving role of BTK inhibitors in CLL, FL, and MCL, emphasizing personalized treatment approaches and adverse event management. • Zanubrutinib shows promise in relapsed/refractory follicular lymphoma, with the ROSEWOOD trial demonstrating improved overall response rates compared to obinutuzumab alone. • Emerging data suggest potential benefits of chemotherapy-free regimens in MCL, with BTK inhibitors playing a crucial role in frontline treatment strategies. • Sequencing and switching of BTK inhibitors are becoming more common, with real-world data indicating potential advantages for zanubrutinib in first- and second-line CLL/SLL therapy.

FDA Approves SpringWorks' Gomekli (Mirdametinib) for Neurofibromatosis Type 1

6 months ago

• The FDA has approved Gomekli (mirdametinib) for both adult and pediatric patients with Neurofibromatosis Type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. • Approval was based on Phase 2b ReNeu trial data, demonstrating a 41% ORR in adults and 52% in children, alongside deep and durable tumor volume reductions and manageable safety profiles. • Gomekli is the first and only medicine approved for both adults and children with NF1-PN, addressing a significant unmet need, particularly for adult patients who previously lacked approved treatments. • SpringWorks received a rare pediatric disease priority review voucher from the FDA, potentially expediting the review of future drug candidates.

Melanoma Treatment Landscape Evolves with Novel Immunotherapies and Targeted Approaches

7 months ago

• The FDA granted fast-track approval to Amtagvi, a Tumor-Infiltrating Lymphocyte (TIL) therapy, for metastatic melanoma patients who have failed other treatments, marking a significant advancement in cellular immunotherapy. • Neoadjuvant immunotherapy has become the standard of care for stage III melanoma patients with resectable tumors, as highlighted at the European Society for Medical Oncology (ESMO) Congress. • Over 170 melanoma pipeline therapies are under development by 150+ companies, including IO Biotech, Moderna, Merck, and BioNTech, targeting various stages and mechanisms of the disease.

AI Shows Promise and Limitations Across Multiple Cancer Care Applications

8 months ago

• AI demonstrates significant potential in cancer diagnosis, with deep learning models achieving up to 94% accuracy in lung cancer prediction and substantially improving radiologist performance in image analysis. • Recent studies show AI language models reaching 85% accuracy on medical oncology exam questions, though concerns remain about potential clinical harm from incorrect responses. • AI applications are expanding into clinical trial design, patient recruitment, and treatment optimization, with ongoing trials evaluating AI platforms for immunotherapy and chemotherapy dose management.

Starton Therapeutics' On-Body Injector Successfully Delivers Lenalidomide for Cancer Treatment

8 months ago

• Starton Therapeutics successfully used BD's on-body injector to deliver its low-dose lenalidomide formulation, STAR-LLD, offering continuous subcutaneous delivery. • A Phase Ib trial of STAR-LLD in multiple myeloma met its primary and secondary endpoints, showing promise compared to oral Revlimid (lenalidomide). • Starton plans to initiate larger Phase II trials in 2025 for chronic lymphocytic leukemia and multiple myeloma, expanding the potential use of STAR-LLD. • The on-body technology aims to improve the quality of life for patients by providing a more convenient and tolerable method of lenalidomide administration.

Imetelstat Shows Durable Transfusion Independence in Lower-Risk MDS

8 months ago

• Updated results from the phase 3 IMerge study demonstrate that imetelstat provides sustained red blood cell transfusion independence (RBC-TI) in patients with lower-risk MDS. • The majority of patients responding to imetelstat achieved a durable response, with a median duration of RBC-TI of 51.6 weeks, indicating a clear clinical benefit. • Treatment with imetelstat did not show a detriment in overall survival compared to placebo, suggesting a favorable risk-benefit profile for the drug. • Imetelstat was approved by the FDA on June 6, 2024, for adult patients with low- to intermediate-1–risk MDS and transfusion-dependent anemia.

Brentuximab Vedotin Triplet Shows Significant Survival Benefits in Relapsed/Refractory DLBCL

10 months ago

Interim data from the phase 3 ECHELON-3 study presented at the 2024 ASCO Annual Meeting reveals that adding brentuximab vedotin to lenalidomide and rituximab significantly improves overall and progression-free survival in patients with relapsed/refractory diffuse large B-cell lymphoma, compared to the standard R2 regimen.

Bispecific CD20/CD19 CAR T-Cell Therapy Shows Promising Results in Mantle Cell Lymphoma

2 years ago

• LV20.19 CAR, a novel bispecific CAR T-cell therapy targeting both CD19 and CD20 B-cell antigens, achieved a 100% overall response rate in patients with relapsed/refractory mantle cell lymphoma. • The phase 1/2 trial demonstrated a 92% complete response rate at day 90, with only one relapse observed among 14 patients after 22 months of follow-up. • The therapy showed a favorable safety profile with no grade 3/4 cytokine release syndrome and only 21% of patients experiencing neurotoxicity, suggesting potential advantages over existing CAR T-cell treatments.

Drug Development Updates