Latest news with #Braftovi
Yahoo
3 days ago
- Business
- Yahoo
Pfizer CEO: HHS claims of ‘concealed safety concerns' on mRNA vaccines are ‘completely inaccurate'
Pharmaceutical rivals don't often come to each other's defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu vaccine, claiming that 'mRNA technology remains under-tested,' Pfizer's chief executive is speaking up. 'MRNA probably is the most utilized vaccine in the history of humanity,' Pfizer CEO Dr. Albert Bourla said Friday, noting that there have been about 1.5 billion mRNA vaccine doses against Covid-19 administered worldwide from his company alone – not counting those from Moderna. 'So it is extremely well-tested.' HHS said Wednesday that it was canceling at least $590 million in federal funding the previous administration had granted for Moderna to use its mRNA technology to develop pandemic influenza vaccines, including those against H5 avian flu viruses. The H5N1 strain has infected at least 70 people and killed one in the US since last year. 'We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable,' an HHS spokesperson said, claiming, 'the reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.' Asked his response to those comments, Bourla responded, 'both of them are completely inaccurate.' The pharma giant's chief spoke with CNN on Friday as Pfizer presented new data on a colorectal cancer drug at the American Society of Clinical Oncology, or ASCO, conference in Chicago, the world's largest meeting on cancer research. Pfizer's drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical trial. It's a 'very, very important finding,' Bourla said, noting that colorectal cancer rates, 'particularly among younger people, are skyrocketing right now.' And while Pfizer is making big bets on cancer research, its CEO said he's not taking his foot off the pedal with investment in vaccines either, despite a 'very big gap' between the company and HHS – particularly Secretary Robert F. Kennedy Jr. – on their approaches to the subject. 'The science is proven,' Bourla said. 'The things they will do that will reduce, maybe, vaccination rates will come back and bite us.' Diseases will return, he said, and 'that will not take a long time.' Already, the US is experiencing one of its largest measles outbreaks since the disease was declared eliminated in this country in 2000, and rates of whooping cough, or pertussis, have increased as well. The recurrence of disease probably 'means that immediately they will have to reverse it,' Bourla said, suggesting that there will be public health efforts to increase vaccination rates in response, and 'they will go back to what every country in the world is doing.' Bourla worked with the first Trump administration to advance the company's Covid-19 vaccine through Operation Warp Speed in 2020, although he noted that Pfizer didn't accept federal funding to support vaccine development, only for the purchase of vaccines after the fact. He said that despite the gap on vaccines, 'when you speak with them, including Secretary Kennedy, I have found several topics that we are in, surprisingly, alignment.' Taking on cancer is one key area of agreement, according to the company. Bourla cited executive orders from President Donald Trump encompassing issues like addressing shorter market exclusivity for pills compared with injectable medicines under the Inflation Reduction Act – something the industry calls the 'pill penalty' – drug discounts to hospitals in a program known as 340B, and ratcheting up scrutiny on pharmacy benefit managers' role in drug pricing. 'We are working to address those things as we agree to disagree on the things that divide us,' Bourla said. He noted that he is against the administration's proposed 40% budget cut for the National Institutes of Health, emphasizing that the US is 'the dominant scientific force in biomedical sciences right now, and it is because we have created this ecosystem,' in which NIH funding supports academic research that can lead to new discoveries picked up by the pharmaceutical industry and made into medicines. 'If we break any link of this chain of this large ecosystem,' Bourla said, 'that's not good for us, and actually, it's a gift to our friends in China.' Bourla also took issue with HHS's actions on Covid-19 vaccines in the past two weeks: saying that the US Food and Drug Administration will change the way it approves updated shots for people who aren't in vulnerable groups and that the US Centers for Disease Control and Prevention will no longer recommend Covid-19 vaccines to healthy children and pregnant women. In previous years, Covid-19 vaccines had been updated in a similar way to seasonal flu shots, based on evidence that they generate an immune response; clinical trials that are required to show a vaccine's effect in preventing cases of disease are thought to take too long, potentially, to be feasible every season. What's more, the FDA and its advisers had previously deemed the vaccine updates small enough to not change their safety profile. Asked whether Pfizer would be able to run clinical trials quickly enough to make updated vaccines available to everyone, not just those in vulnerable groups, Bourla said, 'You are raising some very real concerns that we have.' Bourla noted that the implications of the Trump administration's changes to US health agency policies aren't entirely clear. But 'the issue is that that is not based on any scientific data. It's just based on a belief.' 'The appropriate process has not been followed; this is not just: the secretary or someone at a high level issues, let's say, a new rule,' he said. 'You need to follow a process which is reviews, experts, professional staff of FDA and all of that.' Dorit Reiss, a professor of law at UC Law San Francisco, suggested that HHS's 'bad administrative procedure' in announcing the updated CDC recommendations 'will be an issue' if they're challenged in court. Would Pfizer consider filing a lawsuit? 'My initial reaction is that I would prefer to find solutions but not create tensions,' Bourla replied. 'But of course, if we feel that we have to, we will.' Overall, the CEO emphasized that he has found the administration willing to engage in discussions, noting that 'we maintain a very, very close relationship' with the White House. 'I can't complain they don't listen to us,' Bourla said.
Yahoo
3 days ago
- Business
- Yahoo
ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC
Pfizer's Braftovi (encorafenib) combination therapy was shown to reduce the risk of death by nearly half compared to standard of care (SOC) for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutation. The company announced the survival benefit in an abstract at the American Society of Clinical Oncology (ASCO) 2025 conference being held in Chicago, Illinois, between 30 May and 3 June. The results will be presented on the first day of the conference by Dr Elena Élez, co-principal investigator of the BREAKWATER trial, including primary progression-free survival (PFS) data and updated analysis of overall survival (OS). The presentation includes new data from Pfizer's Phase III trial (NCT04607421) of Braftovi in combination with Eli Lilly's Erbitix (cetuximab) and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) in mCRC patients with BRAF V600E mutation. In the study, the regimen elicited a 47% decreased risk of disease progression, with median PFS for treated patients at 12.8 months versus 7.1 months with SOC. An updated analysis of the trial's key secondary endpoint also shows the regimen led to a median OS of 30.3 months compared to 15.1 months with SOC, equating to a 51% reduction in risk of death for patients. As per a 30 May press release, Élez said: 'The BREAKWATER results are the first promising survival outcomes ever reported for BRAF-mutant mCRC in the first-line setting.' The combination was previously approved by the US Food and Drug Administration (FDA) for adult mCRC patients with CRAF V600E mutation following prior therapy in April 2020. The regimen has since gained accelerated approval as a first-line treatment in December 2024, based on interim overall response rate (ORR) data from the BREAKWATER study, with the full approval contingent on continued demonstration of efficacy. Braftovi is a small-molecule inhibitor of BRAF, a protein involved in tumour cell growth, while Erbitux is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR). GlobalData projects the drugs to generate total annual sales of $1.14bn and $1.98bn by 2031, respectively. GlobalData is the parent company of Clinical Trials Arena. Pfizer's hopes to entrench Braftovi as part of the SOC for mCRC were expressed by the company's chief oncology development officer, Dr Joanna Bendell. Colorectal cancer is the third most common type of cancer globally, and BRAF V600E mutations occur in between 8% and 12% of patients. Presently, this subpopulation of patients exhibits a risk of mortality double that of patients with no known BRAF mutation. "ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC" 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 while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
3 days ago
- Business
- Yahoo
ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC
Pfizer's Braftovi (encorafenib) combination therapy was shown to reduce the risk of death by nearly half compared to standard of care (SOC) for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutation. The company announced the survival benefit in an abstract at the American Society of Clinical Oncology (ASCO) 2025 conference being held in Chicago, Illinois, between 30 May and 3 June. The results will be presented on the first day of the conference by Dr Elena Élez, co-principal investigator of the BREAKWATER trial, including primary progression-free survival (PFS) data and updated analysis of overall survival (OS). The presentation includes new data from Pfizer's Phase III trial (NCT04607421) of Braftovi in combination with Eli Lilly's Erbitix (cetuximab) and mFOLFOX6 chemotherapy (fluorouracil, leucovorin, and oxaliplatin) in mCRC patients with BRAF V600E mutation. In the study, the regimen elicited a 47% decreased risk of disease progression, with median PFS for treated patients at 12.8 months versus 7.1 months with SOC. An updated analysis of the trial's key secondary endpoint also shows the regimen led to a median OS of 30.3 months compared to 15.1 months with SOC, equating to a 51% reduction in risk of death for patients. As per a 30 May press release, Élez said: 'The BREAKWATER results are the first promising survival outcomes ever reported for BRAF-mutant mCRC in the first-line setting.' The combination was previously approved by the US Food and Drug Administration (FDA) for adult mCRC patients with CRAF V600E mutation following prior therapy in April 2020. The regimen has since gained accelerated approval as a first-line treatment in December 2024, based on interim overall response rate (ORR) data from the BREAKWATER study, with the full approval contingent on continued demonstration of efficacy. Braftovi is a small-molecule inhibitor of BRAF, a protein involved in tumour cell growth, while Erbitux is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR). GlobalData projects the drugs to generate total annual sales of $1.14bn and $1.98bn by 2031, respectively. GlobalData is the parent company of Clinical Trials Arena. Pfizer's hopes to entrench Braftovi as part of the SOC for mCRC were expressed by the company's chief oncology development officer, Dr Joanna Bendell. Colorectal cancer is the third most common type of cancer globally, and BRAF V600E mutations occur in between 8% and 12% of patients. Presently, this subpopulation of patients exhibits a risk of mortality double that of patients with no known BRAF mutation. "ASCO25: Pfizer's Braftovi combo boasts 47% drop in disease progression in mCRC" 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
Yahoo
3 days ago
- Business
- Yahoo
Advanced colon cancer patients lived twice as long with a Pfizer combo therapy, trial finds
A combination drug treatment doubled survival time for patients with an aggressive form of colorectal cancer, according to late-stage trial data published Friday in The New England Journal of Medicine and presented at the American Society of Clinical Oncology's annual meeting in Chicago. The three-treatment combination included a standard chemotherapy drug, an antibody drug called cetuximab and a pill from Pfizer called Braftovi, which targets a cancer mutation called BRAF V600E. The mutation shows up in about 10% of patients with colorectal cancer, said Dr. Lionel Kankeu Fonkoua, a gastrointestinal oncologist at the Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota. Patients with the mutation tend to survive for less than a year after diagnosis, and they often don't respond well to standard chemotherapy treatments, said Fonkoua, who wasn't involved with the new trial. According to Pfizer, the risk of death for these patients is more than double compared with those without the mutation. Braftovi was initially approved in 2020 to be used with cetuximab in this group of patients after other treatments had failed. The new trial looked at the drug combination as a so-called first-line therapy. The Food and Drug Administration granted the treatment fast-track approval as a first-line approach in December on the condition that Pfizer provide additional data confirming its effectiveness. The agency often grants fast-track approval to treatments that address serious or life-threatening conditions, especially when there's an unmet medical need. Dr. Christopher Lieu, a professor of medicine at the University of Colorado School of Medicine who wasn't involved with the research, called the results 'very impactful.' 'Patients are clearly living longer, and this represents the new standard of care for this specific subset of patients with this specific mutation,' Lieu said. The trial included more than 600 patients with the mutation who had metastatic colorectal cancer. Patients were randomized to get either the three-drug combination treatment or standard chemotherapy alone. Some of the patients in the latter group were also given bevacizumab, a first-line treatment for metastatic colorectal cancer. The trial found that patients who got the combination treatment lived, on average, about 30 months, compared with about 15 months for those who got standard chemotherapy, with or without bevacizumab. What's more, 47% of patients who got the combination treatment had no disease progression after two years, meaning their cancer didn't grow or spread. The treatment was well-tolerated, with no unexpected safety concerns that would've caused investigators to stop the trial. 'This is a really remarkable finding,' said Dr. Scott Kopetz, a professor of gastrointestinal medical oncology at the MD Anderson Cancer Center in Texas and a co-principal investigator in the trial. 'When we bring this together with standard of care chemotherapy, we get really substantially prolonged survival for these patients that are really unprecedented for this disease type.' More than 141,000 new cases of colorectal cancer are diagnosed in the U.S. each year, making it the fourth most common cancer, according to the Centers for Disease Control and Prevention. About 52,900 people in the U.S. are expected to die from colorectal cancer this year, according to the American Cancer Society. Laurie Ritchie, 61, of St. Louis, got the combination treatment in October 2023. Her results weren't included in the clinical trial analysis. Ritchie had been diagnosed with metastatic colorectal cancer with the BRAF mutation — a diagnosis she describes as 'a huge shock.' Previous colonoscopies hadn't detected cancer; by the time she was diagnosed, the cancer had already reached Stage 4. It eventually spread to her lungs and ovaries. Since she got the combination treatment, she said her blood tests have consistently shown no trace of cancer. While she still worries about the cancer coming back, she says she's now focused on living fully — including going water skiing and downhill skiing. 'I've kind of learned to think of it as something in the trunk, not in the front seat,' she said. 'It still feels a bit like a ticking time bomb inside me, but I think the work I've done on my mental health has really helped me live with it.' This article was originally published on
Bloomberg
3 days ago
- Business
- Bloomberg
Pfizer's Braftovi Doubles Survival in Advanced Colorectal Cancer
A colorectal cancer drug from Pfizer Inc. doubled survival time compared to the standard of care for a subset of patients, data that could change how physicians treat a particularly deadly form of the disease. Adding Pfizer's Braftovi to a cocktail of cancer medicines helped patients with a certain genetic mutation live a median of 30 months, according to data presented at the American Society of Clinical Oncology meeting Friday. Patients given standard treatment, a combination of chemotherapy and the Roche Holding AG drug Avastin, lived for 15 months at the median.
