Tagged News
Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.
NIH's Novel Five-Drug Combination Shows Promise for Relapsed Aggressive B-Cell Lymphoma
• NIH researchers have developed ViPOR, a non-chemotherapy five-drug regimen that achieved complete remission in 38% of patients with relapsed or refractory diffuse large B-cell lymphoma.
• The treatment was particularly effective in two specific subtypes: non-GCB DLBCL (62% complete response) and double-hit GCB DLBCL (53% complete response), offering new hope for patients with limited options.
• At the two-year mark, 36% of all treated patients were still alive and 34% remained disease-free, with some maintaining remission beyond four years despite previously facing poor prognoses.
CARsgen's Satri-cel Shows Promise in Phase 1 Trial for Gastrointestinal Cancers
• Final results from the Phase 1 trial of satricabtagene autoleucel (satri-cel) demonstrate promising efficacy and manageable safety in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly gastric and gastroesophageal junction cancers.
• The groundbreaking CAR T-cell therapy targeting Claudin18.2 represents a significant advancement in solid tumor treatment, with results simultaneously published in Nature Medicine and presented at the 2024 ASCO Annual Meeting.
• Satri-cel has received multiple regulatory designations including RMAT designation from the FDA and PRIME eligibility from the EMA, positioning it as a potential first-in-class therapy globally for Claudin18.2-positive solid tumors.
Related Clinical Trials:
CARsgen Therapeutics Co., Ltd.
Posted 7/11/2023
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020
Peking University
Posted 3/26/2019
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020
Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands
• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations.
• Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA.
• The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.
India's CDSCO Rejects Pfizer's Clinical Trial Waiver for Multiple Myeloma Drug Elranatamab
• India's Subject Expert Committee has rejected Pfizer's request for a local clinical trial waiver for elranatamab, a bispecific antibody targeting relapsed and refractory multiple myeloma.
• Elranatamab, which received accelerated approval from the US FDA based on Phase II data, is a BCMA-directed CD3 T-cell engager designed for patients who have failed multiple prior therapies.
• The decision came after the SEC's oncology meeting on April 3-4, 2024, where they reviewed Pfizer's proposal to import and market the injection in 44mg/1.1mL and 76mg/1.9mL formulations.
FDA Approves ImmunityBio's Anktiva for Bladder Cancer, Marking Major Milestone for Soon-Shiong's Immunotherapy Approach
• The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer, representing a significant breakthrough after years of development and regulatory challenges.
• Anktiva harnesses the body's natural killer cells and T-cells to fight cancer, with clinical trials showing the ability to eliminate bladder cancer cells for at least four years.
• ImmunityBio plans to begin distributing Anktiva to healthcare providers by mid-May 2024, with the company having built a three-year stockpile of the drug during the FDA review process.
Hanmi Pharmaceutical Partners with MSD to Test Novel Bispecific Antibody BH3120 in Combination with KEYTRUDA
• Hanmi Pharmaceutical has entered a Clinical Trial Collaboration and Supply Agreement with MSD to evaluate its novel immunotherapy BH3120 in combination with KEYTRUDA for patients with progressive or metastatic solid tumors.
• BH3120 utilizes Hanmi's proprietary Pentambody platform, targeting both PD-L1 and 4-1BB simultaneously to enhance anti-tumor immune responses specifically in tumor tissues while minimizing systemic immune activation.
• The Phase 1 trial, led by Dr. Kim Dong-wan of Seoul National University Hospital, aims to overcome limitations of existing 4-1BB targeting therapies by leveraging BH3120's demonstrated ability to decouple immune activity between tumor microenvironment and normal tissue.
Volastra Therapeutics Initiates Phase Ib Trial of Sovilnesib for Platinum-Resistant Ovarian Cancer
• Volastra Therapeutics has dosed the first patient in a Phase Ib trial evaluating sovilnesib for platinum-resistant or refractory high-grade serous ovarian cancer, with the FDA granting Fast Track designation for this indication.
• The randomized dose optimization study aims to establish the recommended Phase 2 dose of once-daily oral sovilnesib, addressing a significant unmet need in a patient population with poor treatment response rates.
• Volastra is advancing two chemically differentiated KIF18A inhibitors—sovilnesib and VLS-1488—in parallel clinical trials, while also developing biomarker approaches to measure chromosomal instability through partnerships with Microsoft, Tailor Bio, and Function Oncology.
Related Clinical Trials:
Volastra Therapeutics, Inc.
Posted 4/4/2024
Volastra Therapeutics, Inc.
Posted 10/18/2023
Biovica Signs Master Service Agreement to Support Next-Generation CDK4/6 Inhibitor Development for Breast Cancer
• Biovica International has secured a master service agreement with a biopharmaceutical company to provide TKa testing services for evaluating cell proliferation in drug development studies, with an initial work order valued at 1.2 MSEK.
• The agreement enables Biovica to contribute to the development of first-in-class next-generation CDK4/6 inhibitor therapeutics for breast cancer, potentially leading to a Companion Diagnostic product.
• This partnership adds to Biovica's existing portfolio of 13 master service agreements with pharmaceutical and biotech companies, highlighting growing industry demand for their blood-based cancer monitoring technology.
Promontory Therapeutics Completes Enrollment in Phase 2 Trial of PT-112 for Late-Stage Metastatic Prostate Cancer
• Promontory Therapeutics has completed enrollment of 109 patients in its Phase 2 trial of PT-112 for metastatic castration-resistant prostate cancer (mCRPC) across 32 clinical sites in the US and France.
• PT-112, the first small-molecule conjugate of pyrophosphate in clinical oncology development, works by inhibiting ribosomal biogenesis to induce immunogenic cell death in "immune-cold" prostate cancer.
• The study targets heavily pre-treated patients who have received at least three prior therapies, with topline safety and efficacy results expected in late 2024 following planned FDA meetings.
Related Clinical Trials:
Promontory Therapeutics Inc.
Posted 7/1/2014