Search Results for “ oncology” – Page 45 – media

Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission ...
- Source: drugdu
- 125
- June 12, 2023
Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
- Source: drugdu
- 119
- June 11, 2023
AstraZeneca to stop post-marketing study of Andexxa following early success

AstraZeneca (AZ) has announced that it will stop its post-marketing study of bleeding reversal agent Andexxa (andexanet alfa) after the trial met its primary endpoint earlier than planned. The phase 4 ANNEXA-I study has been assessing the safety and efficacy of the drug versus standard care in more than 450 patients experiencing an intracranial haemorrhage who have received oral Factor Xa-inhibitor treatment, including apixaban and rivaroxaban. Results from a planned interim analysis of the trial showed that Andexxa-treated patients experienced superior haemostatic efficacy – the ability to limit the expansion of a potentially life-threatening bleed in the brain – compared with the control arm, leading the data monitoring board to recommend that the study be ended. Millions of people worldwide depend on Factor Xa inhibitors to manage their risk of blood clots developing, but these medicines carry a small but significant risk of an acute major bleed. AZ reports that ...
- Source: drugdu
- 111
- June 11, 2023
’ Seagen CEO talks about his next stop, Pfizer deal and the ADC landscape

David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
- Source: drugdu
- 187
- June 10, 2023
Janssen shares positive phase 3 results for erdafitinib in bladder cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has shared positive results from a late-stage study of erdafitinib in urothelial carcinoma, the most common type of bladder cancer. Urothelial carcinoma accounts for approximately 90% of bladder cancer cases, and up to 20% of patients diagnosed with metastatic urothelial carcinoma have an FGFR genetic alteration. Despite most urothelial carcinomas being diagnosed at an early stage, rates of recurrence and disease progression are high and a significant proportion of patients who undergo radical surgery will experience disease recurrence. Martin Vogel, EMEA therapeutic area lead oncology, Janssen-Cilag GmbH, said: “Bladder cancer, of which urothelial carcinoma is the most common form, carries a high burden of disease for patients… Patients with advanced urothelial carcinomas, including FGFR-driven tumours who have exhausted standard treatment options, can face a particularly poor prognosis.” Results from an interim analysis of cohort 1 in the phase 3 THOR trial, ...
- Source: drugdu
- 118
- June 10, 2023
Study

The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” William Dupont (Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center) said, “A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” The study investigated the Pan-Cancer Atlas of 10,652 patents ...
- Source: drugdu
- 127
- June 9, 2023
Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
- Source: drugdu
- 108
- June 9, 2023
Study

Reviewed by Lily Ramsey, LLMJun 7 2023 The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” William Dupont, Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center The study investigated ...
- Source: drugdu
- 128
- June 8, 2023
Amgen’s Lumakras shows promise in phase 3 lung cancer study

Amgen has shared positive results from a late-stage study evaluating its KRAS inhibitor, Lumakras (sotorasib), in certain lung cancer patients. The phase 3 CodeBreaK 200 trial compared Lumakras to docetaxel chemotherapy in patients with previously treated, locally advanced and unresectable or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). New data from the trial was presented at the American Society of Clinical Oncology (ASCO) annual meeting. NSCLC represents up to 85% of all lung cancer diagnoses. KRAS G12C is the most common KRAS mutation in NSCLC, Amgen reports, and patients with this mutation whose first-line treatment has failed face limited options. According to data from a post-hoc analysis of CodeBreaK 200, which included NSCLC patients with treated or stable central nervous system (CNS) lesions at baseline, Lumakras was associated with a delayed time to CNS progression and longer CNS progression-free survival (PFS) compared with docetaxel. Additionally, an assessment of CNS tumour shrinkage following ...
- Source: drugdu
- 151
- June 8, 2023
Johnson & Johnson’s Balversa tops chemotherapy in bladder cancer trial

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
- Source: drugdu
- 172
- June 7, 2023

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