Johnson & Johnson

Calquence is forecast to generate up to $4.7bn in sales by 2030, as per GlobalData intelligence. Credit: Nadezhda Fedrunova via Getty Images. AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib), for first-line use in mantle cell lymphoma (MCL). This approval makes Calquence the first BTK inhibitor available for adults with untreated MCL who are unsuitable for autologous haematopoietic stem cell transplantation (HSCT) and allows its use in combination with chemoimmunotherapy. The FDA granted approval based on data from the Phase III ECHO trial (NCT02972840). The randomised, double-blind, placebo-controlled study enrolled 598 patients aged 65 or older with untreated MCL who were unsuitable for HSCT. Patients were randomised to receive Calquence with chemotherapy bendamustine and Biogen and Genentech’s Rituxan (rituximab) or placebo plus bendamustine and Rituxan. Efficacy was measured by progression-free survival (PFS) and evaluated by an independent review committee. The median PFS was 66.4 months in the Calquence plus BR arm, compared to 49.6 months in the placebo plus bendamustine and Rituxan arm. The trial demonstrated a 27% improvement in PFS for Calquence over placebo. MCL is a rare and aggressive subtype of non-Hodgkin lymphoma, often diagnosed in later stages and characterised by the malignant transformation of B lymphocytes in the lymph node mantle zone. Calquence, a next-generation selective and irreversible BTK inhibitor, binds covalently to the BTK active site to inhibit enzymatic activity, suppressing the proliferation and survival of malignant B cells. AstraZeneca’s Calquence now holds a first-mover advantage in the treatment-naive MCL market, outpacing competitors such as BeiGene’s Brukinsa (zanubrutinib), Eli Lilly’s Jaypirca (pirtobrutinib), InnoCare’s Inokai (orelabrutinib), all of which remain in late-stage clinical trials for this indication. AbbVie and Johnson & Johnson’s (J&J’s) Imbruvica (ibrutinib) was previously positioned to lead the market but lost its accelerated approval in 2023 after the Phase III SHINE trial (NCT01776840) showed no overall survival benefit and a 7% increase in mortality risk for Imbruvica-treated patients. GlobalData projects that Calquence could generate up to $4.7bn in sales by 2030. With this FDA approval, AstraZeneca is poised to capitalise on its lead in the competitive BTK inhibitor market. GlobalData is the parent company of Pharmaceutical Technology.

MedRes International has expanded its Nitinol Technology Center in Carlsbad, California, leaders of the medical device contract developer and manufacturer said in an exclusive interview with Medical Design & Outsourcing . It’s the latest nitinol supply chain development as demand booms for the medtech material and the minimally invasive devices it makes possible, ranging from catheter-delivered implants to new therapies for leading killers such as heart disease, stroke and hypertension. MDO webinar: Nitinol knowledge with former Edwards Lifesciences Engineering SVP Ming Wu Budapest-based MedRes opened the Carlsbad facility last summer. Its $1 million expansion includes expanded access to development and design services including prototyping, testing and materials science expertise, plus additional manufacturing capacity and a second line planned for mid-2025. “At MedRes, we apply deep expertise to advance nitinol technology in support of our clients and their medical device innovation,” MedRes CEO Attila Meretei said in an email. “We strive to empower our customers to de-risk their development process with design insights and unmatched development and production capabilities and to bring their innovations to market in less time and at lower cost. If we do our job well, new health care solutions reach patients sooner and will be more broadly available.” Meretei was previously a business development VP at Confluent Medical Technologies. He tapped two other former Confluent executives to lead the MedRes nitinol business: MedRes Chief Operating Officer Christine Trepanier (formerly chief technology officer at Confluent) and MedRes Chief Technology Officer Craig Bonsignore (formerly technical services VP at Confluent). Trepanier and Bonsignore — whose careers overlapped in the 1990s and 2000s as engineers at Johnson & Johnson, where Meretei worked in marketing — are now joined by MedRes VP of Business Development Steve Parmelee, who was previously senior director of business development at Confluent. “The three of us have been working with nitinol for decades,” Trepanier said in an interview. “We have decades of experience designing products, manufacturing products, developing processes for products and selling products. It’s our passion for nitinol that brought us together, and also our passion to partner with customers — partnering with them to really leverage our decades of experience to bring their products to market faster.” They see a need in the nitinol market to better serve medical device startups and established OEMs on complex projects, especially where they can reduce expenses through their product design and development experience. “We can design less costly products, use less nitinol, and improve processes to improve our yields and minimize waste,” Trepanier said. “There was a lot of discussion about supply chain last year and some of the challenges. We are in a unique position to work with multiple suppliers … so we can validate different sources to mitigate the risk of availability and rising costs of the material.” They’ve already been working on early-stage cardiovascular implants and instruments and also have experience with orthopedic, neuro and gastrointestinal devices. “We think there is a lot of opportunity in other systems,” Bonsignore said. “NOTES (natural orifice transluminal endoscopic surgery) is particularly interesting with devices where there’s a lot of nitinol and similar sorts of things being used off-label… by more pioneering interventionists and surgeons.” The MedRes team plans to officially announce their expanded nitinol offerings next week and will be at MD&M West Booth No. 2422 to share more in February. “We’ve had some very informative experiences in our careers, and we have a point of view for how to kind of tackle these sorts of projects,” Bonsignore said. “We think there should be more of what we do in the world, and we’re here to build it.” MD&M West 2025 preview: Medtech suppliers to know at the show in Anaheim

AstraZeneca’s Calquence became the first BTK inhibitor approved in the US for first-line use in mantle cell lymphoma on Thursday. The drug may now be used in combination with chemoimmunotherapy in adults who can’t be treated with autologous hematopoietic stem cell transplantation. The FDA granted the accelerated approval based on the 27% benefit over placebo on progression-free survival Calquence demonstrated in the Phase 3 ECHO trial last June . This means AstraZeneca can immediately start to capitalize on the lead it has over its nearest rival, BeiGene, whose BTK inhibitor Brukinsa, is still in Phase 3 in first-line MCL. However, there is still a question mark over ECHO’s overall survival endpoint. Data here are not yet mature and findings with Johnson & Johnson and AbbVie’s first-gen BTK, Imbruvica, set a tricky precedent. Imbruvica achieved a median PFS benefit of nearly 28 months in its Phase 3 first-line MCL trial, more than the nearly 17 months the second-gen Calquence showed in ECHO. But Imbruvica’s PFS success did not translate into an improvement in OS, and Imbruvica was not approved for first-line disease. More drastically, in April 2023 J&J withdrew the drug from the US market in the second line setting. It is not clear when full OS data from Calquence’s trial might emerge, though the earlier ECHO data showed a positive trend on this endpoint. PFS data from the Phase 3 trial of Brukinsa in first-line MCL will likely not appear for another couple of years. The study is testing BeiGene’s BTK in combination with Rituxan versus a bendamustine-Rituxan combo. Calquence obtained accelerated US approval in second-line MCL in 2017; on Thursday this was converted into full approval.