On July 23, 2025 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for Blenrep combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (Press release, GlaxoSmithKline, JUL 23, 2025, View Source [SID1234654480]). The new Prescription Drug User Fee Act (PDUFA) action date is 23 October 2025 and provides the FDA with time to review additional information provided in support of the application.

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The BLA is supported by efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival versus a daratumumab-based triplet in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.

GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review.

Blenrep combinations are currently approved in the UK2, Japan3, Canada, Switzerland (DREAMM-8 only at this time) and the United Arab Emirates. Applications are currently under review in all major markets globally, including the EU4 and China5 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.6,7 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.9 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.10,11

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
Blenrep combinations were approved in relapsed or refractory multiple myeloma in the UK in April 2025.

In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets available on the MHRA Products website.12

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5 mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was progression-free survival (PFS) as per an independent review committee, with secondary endpoints including overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

PFS results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.13,14

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5 mg/kg intravenously for the first cycle and then 1.9 mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

At the primary analysis at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5). A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned.

With additional follow-up, a clinically meaningful benefit continued to be observed, with a near-tripling of the median PFS for the Blenrep combination versus the bortezomib combination (32.6 months versus 12.5 months, respectively (HR: 0.49 [95% CI: 0.35-0.68]). At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics.

Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.15 Updated PFS results were presented at European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) 2025.

On July 23, 2025 Dispatch Bio reported its official launch, with a mission to engineer a universal treatment across solid tumors, which represent approximately 90% of cancers worldwide (Press release, Dispatch Bio, JUL 23, 2025, View Source [SID1234654496]).

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Immunotherapies have struggled to effectively treat solid tumors due to two main challenges: the lack of a tumor-specific target and the presence of an immune-suppressive tumor microenvironment. Dispatch’s first-in-class Flare platform was specifically engineered to overcome both. It works by delivering a viral vector carrying a novel, universal antigen – called Flare – that precisely tags solid tumor cells while simultaneously breaking down the tumor’s inhibitory environment. Once in place, the Flare antigen acts as a beacon, directing the immune system to find and clear the cancer cells — without harming healthy tissue.

"At Dispatch, we are leveraging the ideal tumor target – one that is only expressed by the tumor cells in a patient – and advances in cell therapy engineering and immune system activation at the right place, at the right time, to get to deep and durable responses in cancer," said Sabah Oney, Ph.D., Chief Executive Officer of Dispatch. "This work matters deeply to me, as it does to so many whose lives have been touched by cancer. We’ve built a strong scientific foundation, assembled an exceptional team and developed innovative technology that give us a real shot at making a difference. We are fully committed to doing everything we can for patients who urgently need new options."

Dispatch was established through a pivotal collaboration with the Parker Institute for Cancer Immunotherapy (PICI) and convergence of groundbreaking technologies from the laboratories of Andy Minn, M.D., Ph.D.; Carl June, M.D.; Chris Garcia, Ph.D.; and Kole Roybal, Ph.D.

"With this confluence of innovative technologies from the labs across PICI, we are poised to shift how cancer therapies are conceived," said Sean Parker, founder and chairman of PICI, as well as a member of Dispatch’s board of directors. "We can now pursue the ultimate goal – a universal cure for most solid tumor cancers – using cutting-edge modalities."

Renowned Leadership and Pioneering Scientists

Since its founding in 2022, Dispatch has focused on building a world-class leadership team and executing its broad pipeline of programs. The founding team at Dispatch includes:

Scientific Co-Founders

Andy Minn, M.D., Ph.D., Chair of Immuno-Oncology at Memorial Sloan Kettering Cancer Center
Carl June, M.D., PICI Center Director and the Richard W. Vague Professor in Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania
Chris Garcia, Ph.D., Professor of Structural Biology and Molecular and Cellular Physiology at Stanford School of Medicine, Stanford University
Kole Roybal, Ph.D., PICI Center Director and Professor of Microbiology and Immunology at University of California, San Francisco
Board of Directors

Jeff Marrazzo, Chairman; Co-founder and Former CEO, Spark Therapeutics
Jake Bauer, Venture Partner, ARCH Venture Partners
John Connolly, Ph.D., Chief Scientific Officer, PICI
Robert Nelsen, Co-founder and Managing Director, ARCH Venture Partners
Sabah Oney, Ph.D., Chief Executive Officer, Dispatch
Sean Parker, Founder and Chairman, PICI
Steve Gillis, Ph.D., Managing Director, ARCH Venture Partners
Leadership Team

Sabah Oney, Ph.D., Chief Executive Officer
Barbra Sasu, Ph.D., Chief Scientific Officer
Chris Wiwi, Ph.D., Senior Vice President, Technical Operations
Jennifer Flaisher, Chief People and Culture Officer
Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer
Naveen Bazaj, Senior Vice President, Corporate Development
Scientific Advisory Board

Kole Roybal, Ph.D., University of California, San Francisco; SAB Chairman
Andy Minn, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Antoni Ribas, M.D., Ph.D., University of California, Los Angeles
Anusha Kalbasi, M.D., Stanford University
Brad Rosenberg, M.D., Ph.D., Icahn School of Medicine at Mount Sinai
Carl June, M.D., University of Pennsylvania
Chris Garcia, Ph.D., Stanford University
Christine Brown, Ph.D., City of Hope
David Kirn, M.D., 4D Molecular Therapeutics; University of California, Berkeley
John Connolly, Ph.D., PICI
Kristen Hege, M.D., University of California, San Francisco
Lisa Coussens, M.D., Ph.D., FAACR, Oregon Health & Science University
Matt Porteus, M.D., Ph.D., Stanford University
Series A Funding to Support First-in-Human Studies

The Series A syndicate includes founding investors ARCH Venture Partners and PICI, along with Bristol Myers Squibb, the University of Pennsylvania, Stanford University, and Alexandria Venture Investments. With this recently closed funding round, Dispatch has raised a total of $216 million to date.

Proceeds from the financing will be used to advance the company’s therapeutic candidates into first-in-human clinical studies and beyond, with the first program expected to enter the clinic in 2026.

"We are on the wave of a revolution in cancer therapy, where innovations like Dispatch’s tumor-agnostic approach to immunotherapy have the potential to treat a majority of solid tumors," said Steve Gillis, Ph.D., board member of Dispatch and managing director at ARCH Venture Partners. "We are excited to support the Dispatch team as they continue to advance their programs."

On July 13, 2025 MAA Laboratories Inc., a specialty pharmaceutical company focused on developing value-added and clinically differentiated drug products, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Nintedanib Esylate Nanoparticle Tablets, developed using the company’s proprietary NanoCont technology platform (Press release, MAA Laboratories, JUL 23, 2025, View Source [SID1234654481]).

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This regulatory milestone enables MAA Laboratories to initiate its Phase I clinical trial in healthy volunteers under the FDA’s 505(b)(2) regulatory pathway.

"We are pleased to receive IND clearance from the FDA for our second clinical-stage product," said Anjani Jha, Founder and CEO of MAA Laboratories. "This milestone continues to validate the potential of our NanoCont platform to deliver enhanced oral drug products with meaningful clinical and development advantages."

On July 23, 2025 Nerviano Medical Sciences Srl (NMS Srl or NMS), a clinical stage biopharmaceutical leader in oncology innovation, reported its strategic plan to focus its research and development resources to progress its three biological targets, composed of PARP1, PARP7, and MPS1, and on its proprietary ADC platform composed of novel ADC payloads (Press release, Nerviano Medical Sciences, JUL 23, 2025, View Source [SID1234654482]).

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Itareparib (PARP1 Inhibitor)
A next-generation, highly selective PARP1 inhibitor engineered to avoid PARP trapping, a key source of toxicity in healthy cells. Its differentiated profile enables safe and effective combination with DNA-damaging agents like chemotherapy and ADCs. Currently in Phase II for relapsed glioblastoma (IDH wild type) in combination with temozolomide, itareparib has shown strong bone marrow tolerability1 supporting its expansion into astrocytoma, small cell lung cancer, and non-BRCA ovarian cancer.

Atamparib (PARP7 Inhibitor)
A potent, oral PARP7 inhibitor targeting tumors driven by mono-ADP ribosylation activity. With high selectivity and a strong safety profile in early trials, atamparib offers a novel approach in oncology where PARP7 plays a critical role in disease progression. Positioned for Phase II entry in 2025, it addresses significant unmet needs in targeted patient populations.

NMS-153 (MPS1/TTK Inhibitor)
A selective mitotic kinase inhibitor designed to disrupt cancer cell division and trigger immune-activating cell death. Currently in Phase I/II for hepatocellular carcinoma in combination with Atezolizumab, MPS1 has shown confirmed responses in monotherapy2 and combination activity in preclinical models, offering a versatile mechanism for tumors resistant to standard therapies.

ADC Platform
A next-generation ADC platform centered on proprietary novel payload-linker technologies designed to overcome drug resistance. The platform offers a compelling balance of potency and safety, with modular design enabling seamless integration with external antibody assets. NMS’s ADC platform can support the expansion of NMS’s own internal ADC pipeline and a growing network of external collaborations.

While NMS’s three biological targets exhibit compelling differentiation based on strong preclinical validation and favorable emerging clinical data, its ADC platform also has potential for strong growth based on advanced next-generation payloads.

In order to focus its research and development resources on the above activities, NMS Srl has informed its unions and employees of its intention to wind down laboratory operations at the BioN campus in Nerviano, Italy. NMS Srl will also relocate its office-based operational headquarters to Corsico (Milan), Italy.

"This is a pivotal moment for NMS," said Hugues Dolgos, Pharm.D., CEO of NMS. "By streamlining operations and strategically focusing our research and development resources efforts on our most promising biological targets and clinical assets, we are taking decisive steps to drive our long-term success based on our unique successful history and capabilities."

NMS expects the transition to be implemented immediately after the conclusion of the information and consultation procedure with labor unions. NMS’s clinical programs and business development activities will continue and will not be affected during or after the information and consultation procedure.

On July 23, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to elironrasib, the company’s RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor (Press release, Revolution Medicines, JUL 23, 2025, View Source [SID1234654483]).

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The Breakthrough Therapy Designation is based on data from the Phase 1 RMC-6291-001 clinical trial evaluating elironrasib monotherapy in patients with advanced KRAS G12C solid tumors. Results from the trial have demonstrated highly competitive antitumor activity, including differentiated safety and tolerability along with a compelling objective response rate and progression-free survival.

"There continues to be a need for new targeted therapies for patients with RAS-addicted cancers, and this Breakthrough Therapy Designation from the FDA highlights the therapeutic potential of elironrasib, a differentiated inhibitor, for patients with KRAS G12C lung cancer," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Coming shortly after daraxonrasib was granted a designation for patients with advanced RAS mutant pancreatic cancer, this designation for elironrasib further validates our innovative product engine as a source for novel potential treatment approaches for patients with RAS mutant cancers."

Elironrasib is an innovative inhibitor that binds selectively and covalently to the oncogenic RAS(ON) form of the RAS G12C variant that drives approximately 12% of cases of NSCLC. Revolution Medicines is exploring elironrasib monotherapy and combinations in various treatment settings and continues work to prioritize multiple options for advancing its development.

NSCLC accounts for 80%-85% of all lung cancers, and most patients have advanced or metastatic disease at initial diagnosis.1,2 KRAS mutations are found in nearly 30% of NSCLC cases, among which KRAS G12C is the most common. Currently there are no RAS-targeted inhibitors with full approval by the FDA to treat patients with KRAS G12C NSCLC.3

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. Pursuant to FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

About Non-Small Cell Lung Cancer
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.4 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies.