PharmaFocus Today – Page 161 – media

FDA Grants Accelerated Approval to Iovance’s Amtagvi for Unresectable or Metastatic Melanoma

Davy James Amtagvi (lifileucel) becomes the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer. Image credit: Christoph Burgstedt | stock.adobe.com The FDA has granted accelerated approval to Iovance’s Amtagvi (lifileucel) for adults with unresectable or metastatic melanoma who received prior treatment with a PD-1 antibody, and in patients who are BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor. The regulatory action makes Amtagvi the first and only one-time, individualized T cell therapy to gain FDA approval for a solid tumor cancer. “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited ...
- Source: drugdu
- 186
- February 21, 2024
How Digitizing Data Collection and Analysis in Biopharma Can Drive Better, Faster Insights

Moving from spreadsheets to automated data collection and processing is far from easy, but it could revolutionize drug development. It’s time for the biopharma industry to embrace end-to-end digitalization. By UNJULIE BHANOT When it comes to collecting and analyzing data, many biopharma companies are still in the digital dark ages. They process data using tools such as Microsoft Excel, which has a lot of capabilities but isn’t tailored to biopharma. Those that do undergo a digital transformation often install fragmented software tools that generate data in silos, requiring a lot of manpower to consolidate, format and chart the data. This is a laborious process that involves manually collating and assimilating data from disparate systems. As the volume of data generated by the biopharma industry explodes, this fragmented approach simply won’t cut it. Imagine a room full of bioreactors generating process-monitoring data every minute, with cell culture sampling performed a number ...
- Source: drugdu
- 162
- February 21, 2024
FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight ...
- Source: drugdu
- 154
- February 21, 2024
MABWELL’s bio-iron homeostasis macromolecule regulatory drug 9MW3011 received FDA orphan drug designation

MABWELL (SHANGHAI) BIOSCIENCE CO. LTD. (688062.SH), an innovative biopharmaceutical company with a full industrial chain layout, announced that the U.S. FDA has granted orphan drug to the iron homeostasis macromolecule regulatory drug 9MW3011 (R&D code in the U.S.: MWTX-003/DISC-3405) (Orphan Drug Designation, ODD). 9MW3011 is indicated for the treatment of polycythemia vera (PV). Orphan drug designation from the FDA applies to drugs for rare diseases that affect fewer than 200,000 patients in the United States. Orphan drug designation can bring policy benefits to drug developers, including assistance during the drug development, clinical fee reductions, and seven years of market exclusivity after approval. 9MW3011 has been undergoing clinical trial in China and the United States and received FDA fast track designation in September last year. About 9MW3011 9MW3011 is an anti-TMPRSS6 monoclonal antibody independently developed by MABWELL’s San Diego Innovation R&D Center in the United States. It can upregulate the level ...
- Source: drugdu
- 124
- February 21, 2024
GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia

GSK’s Omjjara (momelotinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for myelofibrosis-related splenomegaly or symptoms in adults with moderate-to-severe anaemia. The agency’s final draft guidance applies to both newly diagnosed and previously treated patients, although those eligible will need to have either not been treated with JAK inhibitors before or been treated with Novartis’ Jakavi (ruxolitinib). Estimated to affect more than 1,900 people in England, Wales and Northern Ireland, myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells. About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis and nearly all patients develop anaemia at some point over the course of their disease. Omjjara is a once-a-day oral JAK1/JAK2 and ACVR1 inhibitor that aims to address the key manifestations of the disease. NICE’s recommendation comes shortly after the Medicines and Healthcare ...
- Source: drugdu
- 158
- February 21, 2024
Daiichi Sankyo and AstraZeneca’s lung cancer antibody set for FDA review

It is shaping up to be a big year for AstraZeneca in lung cancer treatments. Following another approval win for its blockbuster immunotherapy drug Tagrisso (Osimertinib) in non-small cell lung cancer (NSCLC), another drug could be on the way later this year. The US Food and Drug Administration (FDA) has accepted for review Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy, as per a 19 February press release. The outcome of the FDA’s decision will only be known later this year, with a Prescription Drug User Free Act (PDUFA) date set for 20 December 2024. AstraZeneca and Daiichi Sankyo’s Dato-DXd is a TROP2-directed antibody-drug conjugate (ADC). TROP2 is a protein highly expressed in many types of lung cancers. The drug has demonstrated positive results in the Phase III TROPION-Lung01 ...
- Source: drugdu
- 137
- February 21, 2024
Gilead signs antibody deal with Biocytogen amid ADC buzz

Biocytogen Pharmaceuticals shared plans for its new antibody evaluation and option agreement with Gilead Sciences. In the deal, Gilead will gain access to Biocytogen’s fully human antibody library. The agreement gives Gilead a three-year nomination period to choose its targets of interest and assess the selected antibodies, with the option of acquiring selected antibodies for worldwide therapeutic development. Biocytogen owns four genetically engineered RenMice platforms for the discovery of multiple antibody types. This includes bispecific antibody-drug conjugates (ADC), TCR-mimic antibodies and more. As of June 2023, the China-based company was part of 50 therapeutic antibody and multiple clinical asset co-development, out-licensing and transfer agreements. Earlier this year, Biocytogen partnered with Radiance Biopharma to share its bispecific ADC expertise. The company also signed deals with Ona Therapeutics in December 2023 and Myricx Bio in September 2023 to develop ADCs. This correlates with an uptick in high-value deals recently seen in the ...
- Source: drugdu
- 85
- February 21, 2024
Yet another clinical hold for Gilead’s magrolimab trials

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies. Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). “Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.” The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours. Paliouras said the blood ...
- Source: drugdu
- 155
- February 21, 2024
Health Executives Are Implementing Digital Health, But Aren’t Seeing ROI Yet

Following the Covid-19 pandemic, there has been a boom in the digital health space. But health executives aren’t seeing the financial benefits just yet, according to a recent survey from EY, a consulting firm. The online survey received responses from 101 healthcare executives in the U.S. It found that while 86% of health executives say that digital health solutions have the potential to reduce costs, 70% said they haven’t seen a return on investment so far. In addition, 50% of healthcare organizations say that “siloed tracking metrics” make it hard to follow tech’s initial cost value. “I think we’re still in the early innings of this digital transformation. The Covid episode introduced to the world of U.S. healthcare that, yes, I can interact with my physician remotely and so forth. … We got this first initial wave of incredible excitement and value, but there’s so much work to be done ...
- Source: drugdu
- 139
- February 20, 2024
Astellas’s CAR Tech Deals Speed Up Its Pursuit of In Vivo Cancer Cell Therapies

Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019. By FRANK VINLUAN Cell therapy’s next breakthrough could be the engineering of these cells inside the patient. Two deals more than four years apart put Astellas Pharma in position to ramp up its work developing these in vivo treatments. Under the more recent agreement announced late Thursday, Astellas is collaborating with Kelonia Therapeutics, a startup that has developed technology for precisely delivering genetic cargo to target cells in the body in order to make those cells into in vivo CAR T-therapies. Kelonia calls its technology in vivo gene placement system, or iGPS. The genetic payload delivered to a cell gets it to express a receptor that ...
- Source: drugdu
- 138
- February 20, 2024

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