Don Tracy, Associate Editor Blenrep significantly extended the time to disease progression or death against existing care methods as a second-line treatment for relapsed or refractory multiple myeloma. GSK announced positive results from an interim analysis of its DREAMM-7 head-to-head Phase 3 trial evaluating belantamab mafodotin (Blenrep) as a second-line treatment for relapsed or refractory multiple myeloma. According to a company press release, the trial met its primary endpoint of progression-free survival (PFS) and showed that Blenrep when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma.1 “Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action,” said Hesham Abdullah, SVP, global head, oncology, R&D, GSK, in a press release.1 “We are particularly encouraged by the potential for belantamab mafodotin ...
By Tyler Patchen Pictured: A neurosurgeon analyzes an MRI/iStock, gorodenkoff GSK spinout Autifony Therapeutics has entered into an exclusive global licensing deal potentially worth $770.5 million with Jazz Pharmaceuticals for two different ion channel targets associated with neurological disorders. Under the deal announced on Tuesday, the U.K.-based biotech Autifony will receive an undisclosed upfront payment from Jazz and is eligible to receive development, regulatory and commercial milestone payments as well as royalties on any future net sales. Autifony, which is focused on developing treatments for central nervous system disorders and other brain diseases, will spearhead the drug discovery and the preclinical development of the two ion channel targets. Prior to the completion of preclinical development, Jazz will take over clinical development and assume responsibility for manufacturing, regulatory actions and commercialization. “Jazz has an exceptional track record of rapidly advancing neuroscience development programs and effectively commercializing novel therapies that offer improvements ...
GSK’s momelotinib has been recommended for approval by the European Medicines Agency’s human medicines committee as the first treatment option specifically indicated for myelofibrosis patients with moderate-to-severe anaemia. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Eligible patients will also have either not been treated with JAK inhibitors before or have been treated with Novartis’ Jakavi (ruxolitinib), GSK said. Myelofibrosis is a rare blood cancer that can lead to severely low blood counts, with about 40% of patients having moderate-to-severe anaemia at the time of diagnosis and nearly all patients developing anaemia at some point in the course of their disease. Transfusions are often required by myelofibrosis patients with anaemia and more than 30% will discontinue treatment ...
GSK has announced results from a survey revealing that parents are less knowledgeable about meningitis compared to other childhood infectious diseases. The multi-country GSK-commissioned and funded survey conducted by Ipsos revealed that 72% of over 4,000 parents said they were somewhat knowledgeable or knew a lot about meningitis. However, this result was significantly lower compared to other infectious diseases, including COVID-19 (95%), influenza (94%), measles (86%), pneumonia (82%) and whooping cough (74%). Additionally, 93% of parents across the US, Brazil, Germany, France, Spain, the UK and Italy surveyed said they could not identify the three most common symptoms of the condition: fever, headache and stiff neck. Annually, 2.5 million people are diagnosed with meningitis globally, of which 1.2 million cases are invasive meningococcal disease (IMD). Despite 88% of parents considering meningitis to be a serious childhood illness, only 38% said they believed that their child was at risk of catching ...
By Tristan Manalac Pictured: GSK building in Poland/iStock, Wirestock The FDA on Friday approved GSK’s oral drug momelotinib, now to be marketed under the brand name Ojjaara, for the treatment of myelofibrosis in adults with anemia. Myelofibrosis patients often develop anemia, which forces them to discontinue treatment and raise the need for transfusions. Ojjaara’s approval will help address this “significant medical need in the community” and lead to better outcomes in these patients, Nina Mojas, GSK senior vice president for oncology global product strategy, said in a statement. With Friday’s approval, Ojjaara becomes the first authorized treatment for both newly diagnosed and previously treated myelofibrosis patients with anemia that also targets the key symptoms of the condition, according to the company’s press release. The approval comes after a three-month delay in June 2023, which the FDA said was to give it more time to review additional data supporting the application. ...
Myelofibrosis can already be treated with several drugs from a class of medicines that address a pathway driving this type of blood cancer. A drug from GSK is now the latest entrant into the class, but with an additional component that specifically treats the anemia complication affecting myelofibrosis patients. FDA approval of GSK’s momelotinib covers the treatment of adult myelofibrosis patients regardless of whether or not they have been previously treated with another drug for the cancer. The regulatory decision announced late Friday marks the payoff for the pharmaceutical giant’s bet on a molecule it acquired in a $1.9 billion deal. The GSK drug, known in development as momelotinib, will be marketed under the brand name Ojjaara. In myelofibrosis, inflammation and scar tissue (fibrosis) impair the bone marrow’s ability to normally produce red blood cells. The disease leads to anemia, which must be treated with regular blood transfusions. Other complications ...
GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium. The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy. Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix. The plant will contain two wings: one for producing the UK company’s ‘non-live’ vaccines, and the other for making ‘live’ vaccines, which include Varilrix for chickenpox and Priorix for measles. A spokesperson from GSK said: “The ambition is to have tens of millions of doses lyophilized each year.” “The new centre will feature several cutting-edge technological innovations designed to increase the efficiency of manufacturing processes and reduce environmental impact,” the spokesperson added. In May, Arexvy became the first RSV ...
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
GSK has sued Pfizer in a US court, alleging infringement of the patents it holds on vaccines for respiratory syncytial virus (RSV). The lawsuit claims that Pfizer’s Abrysvo infringes on four of GSK’s patents that cover its rival vaccine, Arexvy. In May, Arexvy became the first RSV vaccine to be approved anywhere in the world after it received approval from the US Food and Drug Administration (FDA). The US approval of Pfizer’s vaccine followed shortly afterwards. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. Both companies’ vaccines aim to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older and are expected to be available in the US before the next RSV season. A GSK spokesperson said that “intellectual property protections ...
By Tristan Manalac The FDA has approved GSK’s Jemperli (dostarlimab-gxly) for the treatment of primary advanced or recurrent endometrial cancer, the company announced Monday. The label expansion covers a combination regimen of Jemperli, carboplatin and paclitaxel, followed by Jemperli as a single agent. Monday’s approval also only applies to patients who are mismatch repair deficient (dMMR), as confirmed by an FDA-approved test, or who have high microsatellite instability (MSI-H). Jemperli is the first immuno-oncology treatment and PD-1 inhibitor to be authorized for frontline use in this patient population, according to GSK. The expanded approval “redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” for whom chemotherapy alone has been the standard of care, though many patients still see disease progression, Hesham Abdullah, GSK’s senior vice president and global head of oncology development, said in a statement. Jemperli is an anti-PD-1 antibody that was first approved ...
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