Search Results for “cancer” – Page 21 – media

Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 96
- January 30, 2024
Bladder Cancer Therapies Developer Raises $380M in the First Biotech IPO of 2024

CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments. By FRANK VINLUAN CG Oncology, a company that turns viruses into cancer therapies, has raised $380 million to fund clinical development of a therapy that the company believes could become a new first-line treatment for certain bladder cancers. The stock offering marks the first biotech IPO of 2024. CG was able to raise much more than planned. In preliminary financial terms set earlier this week, the company projected selling 17 million shares in the range of $16 to $18 each, which would have raised $289 million at the pricing midpoint. When CG finalized the IPO terms late Thursday, it ended up offering 20 million shares priced at $19 apiece. Those shares will trade on ...
- Source: drugdu
- 86
- January 27, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 97
- January 26, 2024
FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
- Source: drugdu
- 90
- January 25, 2024
Bristol Myers shows power of Opdivo-Yervoy combo in first-line colorectal cancer subset

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients. But another approval may have to wait. The dual immunotherapy combo of Opdivo and Yervoy cut the risk of disease progression or death by 79% compared with chemotherapy—with or without targeted therapies—in patients newly diagnosed with metastatic colorectal cancer that was microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR). Investigators shared the results, from the CheckMate 8HW study, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. After about two years of median follow-up, 72% of patients who received the anti-PD-1/CTLA-4 combo were alive without disease progression, versus 14% in the control group. The results “have potentially practice-changing implications” for previously untreated MSI-H/dMMR metastatic colorectal cancer, lead study author Thierry Andre, M.D., from the Sorbonne Université in Paris, said in a ...
- Source: https://www.fiercepharma.com/pharma/bristol-myers-shows-opdivo-yervoy-dual-immunotherapys-power-first-line-colorectal-cancer
- 102
- January 24, 2024
Gilead Drug Fails Pivotal Lung Cancer Study, But Still Might Have Path Forward

Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients. By FRANK VINLUAN Sales for Gilead Sciences cancer drug Trodelvy are growing, but the company is counting on additional approvals to boost the product to blockbuster status and justify the premium price it paid to acquire the therapy. The drug’s failure in a pivotal lung cancer study is a setback to that strategy. Treatment with Trodelvy, an antibody drug conjugate (ADC), fell short of a Phase 3 study’s main goal of showing statistically significant improvement in overall survival in patients with advanced cases of non-small cell lung cancer (NSCLC), Gilead announced Monday. Nevertheless, the company pointed to numerical ...
- Source: https://medcitynews.com/author/fvinluan/
- 179
- January 24, 2024
Opdivo Plus Yervoy Reduces the Risk of Colorectal Cancer Disease Progression or Death by 79% Versus Chemotherapy

Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. Image Credit: Adobe Stock Images/Crystal light The combination of Bristol Myers Squibb’s Opdivo (nivolumab) with Yervoy (ipilimumab) showed significant improvements in progression-free survival (PFS) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)in the Phase III CheckMate -8HW trial. The combination produced a 79% reduction in the risk of disease progression or death compared to chemotherapy, according to the trial. “Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, MD, head of the medical oncology department, Sorbonne University, Hospital Saint-Antoine, Paris, France, in a press release. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 76
- January 24, 2024
Immune checkpoint inhibitor target found to promote skin cancer growth

Programmed cell death 1 (PD-1) is an important target for immune checkpoint inhibitor therapies that block its signaling and boost T-cell activity. PD-1 inhibitors have been approved for treating various types of cancer. But PD-1 functions can vary between different cell and cancer types, either promoting or suppressing disease progression. Merkel cell carcinoma (MCC), a rare and aggressive form of skin cancer, responds well to immune checkpoint inhibitor therapy. However, it was previously unknown if MCC cells express PD-1 themselves, and unclear how exactly cancer cell-intrinsic PD-1 contributes to tumor growth. A study led by investigators from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, identified a new mechanism through which PD-1 promotes MCC progression. Through a series of experiments, the researchers demonstrated PD-1 expression on MCC cells in preclinical models and patient tumor samples. They found that MCC-PD-1 receptor binding to its ligands ...
- Source: drugdu
- 96
- January 23, 2024
Pfizer’s Talzenna recommended by NICE for advanced breast cancer

Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations. Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable. Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation. Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast ...
- Source: drugdu
- 84
- January 23, 2024
World’s First Perioperative Immunization Phase III Study Results in Esophageal Cancer Presented at 2024 ASCO GI

The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) was held in San Francisco from January 18 to 20, local time. As an academic event in the field of gastrointestinal tumors, ASCO GI showcased several heavyweight and innovative scientific advances in the field, especially the release of the Late-breaking Abstract (LBA) study, which will lead the way to a new direction in clinical treatment. Phase III study (ESCORT-NEO/NCCES01), led by Prof. Li Yin of Cancer Hospital, Chinese Academy of Medical Sciences, with the participation of 24 centers across China, was selected as LBA. Professor Li Yin reported the results of the study, which is the world’s first perioperative immunization Phase III study in esophageal cancer. Neoadjuvant carelizumab in combination with chemotherapy showed a significantly better pCR rate than that of neoadjuvant chemotherapy, achieving the primary endpoint without increasing the risk of surgery and with a manageable safety profile. ...
- Source: drugdu
- 81
- January 23, 2024

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