Search Results for “cancer” – Page 35 – media

GSK beats Merck to first PD-1 approval in newly diagnosed endometrial cancer

GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. The FDA has cleared Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer, GSK said Monday. To be eligible for the therapy, the patient’s tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), both terms that describe a type of genetic abormality. The approval comes nearly two months ahead of schedule and puts Jemperli ahead of Merck & Co.’s rival PD-1 inhibitor Keytruda, which is also gunning for the first-line endometrial cancer use. But the dMMR/MSI-H restriction comes as a bit of a disappointment for the GSK drug. By GSK’s estimate, about 15% to 20% of the roughly 60,000 new cases of endometrial cancer each year in the U.S. will be diagnosed at an advanced ...
- Source: drugdu
- 105
- August 2, 2023
Merck, Moderna Launch Pivotal Cancer Vaccine Trial for High-Risk Melanoma

Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
- Source: drugdu
- 138
- July 28, 2023
Elevar Touts First-line Potential of Rivoceranib in Phase III Liver Cancer Trial

Pictured: Illustration of a liver with tumors/iStock, libre de droit A pre-specified primary analysis of the Phase III CARES 310 trial showed that Elevar Therapeutics’ cancer candidate rivoceranib, when combined with fellow investigational drug camrelizumab, significantly improved survival in patients with unresectable hepatocellular carcinoma, the company announced Monday. Patients who received the drug combination saw a 48% reduction in the risk of death or disease progression, an effect that was significantly better as compared with Bayer’s Nexavar (sorafenib), the standard first-line treatment for unresectable hepatocellular carcinoma (uHCC). At the interim analysis, overall survival was also significantly longer in the rivoceranib-camrelizumab group versus Nexavar. Results of CARES 310 showed that “camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” Elevar CEO Saeho Chong said in a statement. The study’s findings were published Monday in the medical journal The Lancet. CARES 310 is a randomized, ...
- Source: drugdu
- 127
- July 27, 2023
Astellas Strikes Another Deal to Expand in Cancer, Partnering With PeptiDream

Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
- Source: drugdu
- 110
- July 27, 2023
SN Bioscience’s Nano-Cancer Therapy Wins Orphan Drug Designation

The US Food and Drug Administration (FDA) granted SN Bioscience an orphan drug designation for its small cell lung cancer (SCLC) drug SNB-101, a polymer nanoparticle drug. The South Korea-headquartered company has received approval to run Phase I clinical trials in the US and South Korea, per a 20 July press release. The US trial (NCT04640480) is with solid tumours for any type of cancer. The orphan drug designation programme is an FDA initiative to support the development of new treatments for rare diseases. The classification gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity after approval. SNB-101 is an intravenously or intratumorally administered drug that acts as a topoisomerase I inhibitor. The therapy causes DNA breaks, inhibiting DNA replication and shutting down the cell cycle to prevent tumour growth. The drug uses the active ...
- Source: drugdu
- 100
- July 25, 2023
Phase III Data Show Keytruda’s Promise in Earlier-Stage Cervical Cancer

Pictured: Merck Research Laboratories headquarters in Silicon Valley/iStock, Michael Vi Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) aced one of its primary efficacy metrics in the Phase III KEYNOTE-A18 study, the company announced Wednesday. Though its news release was sparse with specific data from the study, Merck said that an independent Data Monitoring Committee found that Keytruda with chemoradiotherapy led to a significant and clinically meaningful improvement in progression-free survival (PFS), as compared with chemoradiotherapy alone. “[T]hese results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes,” Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, said in a statement. KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized and double-blinded trial enrolling 980 patients with newly diagnosed, locally advanced cervical cancer. To be eligible, patients must also be classified as high-risk, defined as having stage 1B2 to 2B and lymph ...
- Source: drugdu
- 105
- July 21, 2023
Healthy Breast Fat may Protect Against Invasive Breast Cancer

Researchers have found a possible explanation as to why higher breast density and older age increase the risk of breast cancer. In an innovative study, researchers at the Turku Bioscience Centre, InFLAMES Flagship of the University of Turku, and Turku University Hospital, Finland, have made an extraordinary discovery that turns conventional wisdom on its head. Their findings reveal that healthy fat cells in the breast, also known as adipocytes, secrete a potent factor called IGFBP2, which acts as a barrier against invasive breast cancer progression. Dr. Emilia Peuhu (Study Key Collaborator) said, “Adipocytes generally get a bad rap for promoting cancer progression, but this study demonstrates that healthy breast fat can play a protective role in the maintenance of tissue homeostasis and cancer containment. It’s time to re-evaluate our assumptions and recognize the important role of these unsung heroes.” Breast cancer patients who experience the transition ...
- Source: drugdu
- 101
- July 18, 2023
FDA Clears More Chemotherapy Imports from China’s Qilu Amid Shortage of Key Cancer Meds

As a shortage of key chemotherapy drugs continues to upend cancer treatment across the country, the FDA has resorted to securing some of the meds from China.After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. Canada’s Apotex will distribute the drugs, which are expected to arrive this week, a company spokesperson told Fierce Pharma. Apotex is “very pleased” to aid in addressing the shortage, the spokesperson added. Cisplatin, along with fellow platinum-based chemotherapy carboplatin, are commonly used as a standard of care across many types of cancer. The newest import was first reported by Bloomberg. After the FDA flagged quality issues at a facility that produced the drug, a “ripple effect” ensued across the supply chain, the FDA’s Oncology Center of Excellence chief Richard Pazdur, M.D., told The Cancer ...
- Source: drugdu
- 101
- July 14, 2023
GSK’s Jemperli Made Available to Endometrial Cancer Patients via UK’s Early Access Scheme

GSK has announced that eligible endometrial cancer patients in the UK will be granted early access to its anti-PD-1 therapy Jemperli (dostarlimab) in combination with platinum-containing chemotherapy via the Early Access to Medicines Scheme (EAMS). The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The combination has been specifically indicated to treat adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. Endometrial cancer is the most common gynaecological cancer in the UK, with approximately 10,000 new cases reported each year. While it often has a better prognosis than other womb cancers if diagnosed early, patients with advanced or recurrent disease face limited treatment options and a poor prognosis. The positive scientific opinion from the Medicines and ...
- Source: drugdu
- 114
- July 13, 2023
Astellas Gains FDA Priority Review for Gastric Cancer Therapy BLA

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients. Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive. Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients. A decision on the approval by the regulatory agency is anticipated on 12 January 2024. The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings. Zolbetuximab was assessed along with a regimen comprising oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial. The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX). Astellas immuno-oncology development ...
- Source: drugdu
- 118
- July 11, 2023

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