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 23, 2025 Boston Scientific reported second quarter 2025 financial results (Presentation, Boston Scientific, JUL 23, 2025, View Source [SID1234656858]).

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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 Boston Scientific Corporation reported the company generated net sales of $5.061 billion during the second quarter of 2025, growing 22.8 percent on a reported basis, 21.6 percent on an operational1 basis and 17.4 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 23, 2025, View Source [SID1234656859]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $797 million or $0.53 per share (EPS), compared to $324 million or $0.22 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.62 a year ago.

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"This was another excellent quarter — marked by exceptional top-line performance — that delivered margin expansion and prioritized investment for future growth," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am incredibly grateful to our dedicated global team for demonstrating clinical and commercial excellence across the company and positioning us for differentiated long-term performance."

Second quarter financial results and recent developments:

Reported net sales of $5.061 billion, representing an increase of 22.8 percent on a reported basis, compared to the company’s guidance range of 17.5 to 19.5 percent; 21.6 percent on an operational basis; and 17.4 percent on an organic basis, compared to the company’s guidance range of 13 to 15 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.53 per share, compared to the company’s guidance range of $0.45 to $0.47 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.71 to $0.73 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 15.7 percent reported, 14.7 percent operational and 7.0 percent organic
Cardiovascular: 26.8 percent reported, 25.5 percent operational and 23.2 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 6.8 percent reported and 1.8 percent operational
Asia-Pacific (APAC): 18.0 percent reported and 15.4 percent operational
Latin America and Canada (LACA): 4.0 percent reported and 8.9 percent operational
Emerging Markets4: 11.6 percent reported and 12.1 percent operational

Received U.S. Food and Drug Administration approval to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF) with the FARAPULSE Pulsed Field Ablation (PFA) System.

Commenced enrollment in the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE and FARAPOINT PFA Catheters in patients with persistent AF who previously received a cardiac ablation and experienced a recurrence of the condition.5

Received CE mark for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.

Completed the acquisition of Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.

Completed the acquisition of SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational renal nerve denervation technology designed to treat hypertension.5
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4. Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

5. The FARAPOINT PFA Catheter and the TIVUS Intravascular Ultrasound System are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.