Latest news with #belantamabmafodotin
Yahoo
18-07-2025
- Business
- Yahoo
GSK's Blenrep faces setback as FDA cancer committee votes against approval
The US Food and Drug Administration's (FDA's) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK's Blenrep (belantamab mafodotin) just days before the drug's Prescription Drug User Fee Act (PDUFA) date. This marks a significant setback for the UK-based pharma company, which is aiming to regain approval of the therapy after it was pulled from the US market in 2022 due to concerns raised by late-stage trial data. Blenrep was approved under the FDA accelerated approval process in 2020 to treat multiple myeloma (MM). It is an antibody drug conjugate (ADC) that combines a humanised BCMA monoclonal antibody with the cytotoxic agent auristatin F, linked together by a non-cleavable linker. The ODAC committee had a 7–1 split against the combination of Blenrep plus pomalidomide and steroid dexamethasone and a 5-3 split against the combination of Blenrep with bortezomib and dexamethasone. GSK states it remains confident in the benefit/risk profile of Blenrep as a combination therapy and will continue to work closely with the FDA as they complete the review of the drug in patients with relapsed or refractory multiple myeloma (r/r MM). The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date. The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved. Data supporting the drug's approval comes from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) studies. In the studies, many patients experienced keratopathy and Visual Acuity (KVA) events. All grade KVAs occurred in 92% and 93% of patients in DREAMM-7 and DREAMM-8, respectively, while more serious grade 3-4 events were found in 77% and 78% of patients in the same two studies. Blenrep combinations are approved in r/r MM in the UK and Japan, as well as other markets, including Switzerland, based on the results of DREAMM-8. Applications for approval in the European Union (EU) and China are ongoing, based on the results of the DREAMM-7 study. "GSK's Blenrep faces setback as FDA cancer committee votes against approval" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Sun
13-06-2025
- Health
- The Sun
NHS first in the world to roll out ‘trogan horse' cancer treatment that ‘drastically slows disease'
A "TROJAN HORSE" therapy that sneaks toxic drugs inside and kills cancer cells is being rolled out on the NHS in England in a world first. It can stop the blood cancer myeloma from progressing for nearly three times longer than current therapies. 2 The treatment, known as belantamab mafodotin or Blenrep, is an advanced form of chemotherapy. It delivers a powerful dose of cancer-killing medication directly into cancer cells, while limiting damage to healthy cells, reducing the risk of harsh side effects. Around 1,500 people a year with multiple myeloma, a rare, incurable cancer of the bone marrow, are expected to benefit from the treatment. Paul Silvester, 60, from Sheffield, is one of the first patients to receive the new drug through an early access programme. Diagnosed with myeloma in July 2023, Paul was initially given a different treatment, but when it failed to stop his cancer from progressing, doctors turned to belantamab mafodotin. 'I feel like this treatment has brought the party balloons back in the house,' he said. 'It has been amazing - within the first two or three weeks, after the first dose, I was in remission. "It gives me quite a lot of confidence in the drugs and it makes me more optimistic about the future. "I've been feeling well and I'm still quite active - that's what's important in terms of your quality of life. "One of my daughters is graduating from university in October and it's a goal for me to be there." British rock legend reveals he's fighting aggressive blood cancer and is undergoing treatment The therapy, developed by GlaxoSmithKline, is administered via infusion every three weeks alongside two other drugs: bortezomib and dexamethasone. Clinical trials showed it could delay the progression of myeloma for around three years, compared to just over a year for patients receiving commonly used drug daratumumab with the same combination. Following new guidance from NICE (the National Institute for Health and Care Excellence), the drug has now been approved for widespread NHS use in England. It's the first health system in the world to offer it routinely. Patients who have relapsed or not responded to earlier treatments will now be eligible for the therapy. The treatment has been nicknamed a 'Trojan horse' because of how it works. 2 Much like the famous story from ancient Greek mythology where soldiers hid inside a giant wooden horse to secretly enter the city of Troy, this drug hides a toxic payload inside an antibody that tricks cancer cells into letting it in. Once inside, it releases a powerful, cell-killing molecule that destroys the cancer from within, while sparing surrounding healthy cells. 'New hope' Professor Peter Johnson, NHS England's national clinical director for cancer, said: 'Myeloma is an aggressive type of blood cancer, but we have seen a steady improvement in the outlook for patients over recent years as we have introduced new targeted therapies. 'I am delighted that patients in England will be the first to benefit from this new treatment, which has the potential to keep cancer at bay for years longer, giving people the chance of more precious time with friends and family. 'This treatment could be life-changing for many patients and their families, and that's why it is so important that the NHS continues to secure quick access to the latest, innovative treatments like this, at affordable prices to the taxpayer.' Helen Knight, director of medicines evaluation at NICE, added: 'We're delighted that people in the UK will become among the first in the world to access belantamab mafodotin for this indication. "This recommendation demonstrates our commitment to getting the best care to patients fast, while ensuring value for the taxpayer." Myeloma UK, a charity supporting those with blood cancer, has also welcomed the news. Shelagh McKinlay, its director of research and advocacy, said: 'It's fantastic to see the UK at the forefront of myeloma treatment. 'We have been working very hard for the last year to get this treatment approved and we know it will transform the lives of thousands of people with myeloma.' Health Minister Karin Smyth added: 'This groundbreaking therapy puts the NHS at the forefront of cancer innovation. "By harnessing cutting-edge 'trojan horse' technology, we're offering new hope to blood cancer patients across the country."
BBC News
13-06-2025
- Health
- BBC News
Cancer: World-first 'Trojan horse' therapy to be given on NHS
A "Trojan horse" therapy that sneaks toxic drugs inside cancer cells is being made available on the NHS in England in a world can halt the blood cancer myeloma for nearly three times longer than current drug is an advanced form of chemotherapy that hits cancer with a bigger dose, while reducing Silvester, one of the first people to get it, says the therapy has been "life-changing" and he's now planning history-themed adventures. Myeloma – also known as multiple myeloma – affects part of the immune system called plasma cells. These are made in the spongey bone marrow in the centre of our who is 60 and from Sheffield, was diagnosed nearly two years ago after the cancer led to broken bones in his had a bone marrow transplant last year, but relapsed around Christmas. He has since been on the new therapy – called belantamab mafodotin – as part of an early access weeks he was in remission. Other treatments could have left him isolating in his bedroom for months, so Paul says the therapy "is absolutely life-changing" and was "creating that opportunity to enjoy" life. Visiting Hadrian's Wall is next on the agenda for history buff Paul; and he's looking forward to one of his daughters graduating later this year. "Most people say 'you look really really well'... I have a good normal life," he told the BBC. How does this therapy work? Paul's therapy - belantamab mafodotin – is a lethal chemotherapy drug that has been bound to an antibody, similar to the ones the body uses to fight infection. However, these antibodies have been designed to spot markings on the outside of plasma cells. So they travel to cancerous cells, stick to the surface and are then absorbed. Once inside they release their toxic payload, to kill the cancer. The therapy is named Trojan horse therapy after the siege of the city of Troy in Greek mythology, when a giant wooden horse was used to smuggle soldiers into the cannot be cured, but clinical trials last year showed the Trojan horse therapy halted the cancer for three years, compared to 13 months with current therapies. Prof Peter Johnson, the national clinical director for cancer at NHS England, said the difference was "life-changing".He told me: "This is a really important development for people with myeloma, because although we may not be able to cure the illness, giving them time free of the disease and free of the symptoms is really important."We've seen in the last few years that using antibodies to deliver chemotherapy drugs directly into cells can make a big difference for a variety of different types of cancer." Around 33,000 people are living with myeloma in the UK. The new drug will be used when the first-choice therapy fails, so around 1,500 patients a year could decision comes after a review by the National Institute of Health and Care Excellence (NICE) concluded the drug was cost-effective for NHS use. NICE recommendations are normally adopted in England, Wales and Northern Ireland while Scotland has its own process. The therapy is kinder than other cancer treatments, but is not free from side-effects. After a cancer cell has been destroyed, the remaining chemotherapy drug will leak into the body. This can cause dry eyes and blurred vision. 'These are very smart drugs' The technical name for these drugs is an therapy was developed by GSK in the UK with early research taking place in Stevenage and the first clinical trials in Martin Kaiser, team leader in myeloma molecular therapy at the Institute of Cancer Research, said these "are very smart drugs" and the difference in side effects compared to other drugs "is really remarkable".While myeloma is still considered an incurable cancer, Prof Kaiser says drugs like this are "an important step towards a functional cure" and he thinks long-term remission will go "above 50% in the next five years".Antibody drug conjugates are being developed for a range of cancers. The limitation is being able to design an antibody that can target the cancer alone. There is one that can target some types of breast cancer. Research is already taking place on stomach and bowel McKinlay, from the charity Myeloma UK, said the approval would "transform the lives of thousands" and it was "fantastic to see the UK at the forefront of myeloma treatment".Health Minister Karin Smyth, said: "This ground-breaking therapy puts the NHS at the forefront of cancer innovation."
Medscape
23-05-2025
- Health
- Medscape
Blenrep Gets European Nod to Treat Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma. The drug is an antibody drug conjugate comprising a humanized IgG1κ monoclonal antibody targeting the B-cell maturation antigen (BCMA), conjugated with a cytotoxic agent, maleimidocaproyl monomethylauristatin F (mcMMAF). Belantamab mafodotin binds to BCMA on the surface of myeloma cells, causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity. According to the manufacturer, GSK, it is the first such conjugate to be approved and represents a new mechanism of action compared with existing agents. Generally Poor Prognosis Multiple myeloma is a rare and incurable disease of the plasma cells, typically affecting adults older than 60 years of age. First-line therapy is usually with targeted cancer drugs such as lenalidomide or bortezomib in combination with a steroid, sometimes with chemotherapy and a stem cell transplant. Relapses are treated similarly. The disease has a generally poor prognosis and there is a need for novel effective therapies. Blenrep had been designated as an orphan medicine, and the EMA will now review the information to determine whether this can be maintained. CHMP said that two phase 3, randomized, open-label studies had shown that adding Blenrep to standard therapy of either bortezomib and dexamethasone in patients who have received at least one prior therapy, or pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide, prolonged progression-free survival in patients with relapsed or refractory multiple myeloma. Ocular Side Effects Common The safety and tolerability profiles of the Blenrep combinations were broadly consistent with those of the individual agents. The most common side effects with Blenrep include reduced visual acuity, corneal examination abnormalities (including keratopathy), thrombocytopenia, blurred vision, dry eye, foreign-body sensation in eyes, eye pain, photophobia, eye irritation, neutropenia, anemia, and diarrhea. Patients should have an ophthalmic examination, including visual acuity and slit-lamp examination, by an eye care professional before each of the first four doses of Blenrep, and as clinically indicated thereafter. Patients should be encouraged to inform their physicians of any ocular symptoms. The drug will be available as 70 mg or 100 mg powder for concentrate for solution for infusion. It is administered as a 30-minute infusion every 3 or 4 weeks. Treatment should be prescribed by physicians experienced in the treatment of multiple myeloma. Detailed recommendations will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
