Talquetamab

Johnson & Johnson (J&J) has received a positive recommendation from the UK’s National Institute for Health and Care Excellence (NICE) for TALVEY (talquetamab), for use within the NHS in England and Wales as a treatment option for relapsed and refractory multiple myeloma (RRMM). Multiple myeloma is an incurable blood cancer affecting plasma cells in the bone marrow. When these cells become malignant, they proliferate rapidly and replace healthy cells, forming tumours. Approximately 6,200 new cases are diagnosed in the UK each year, and an estimated 33,000 people are currently living with the disease. Symptoms may include bone pain, recurrent infections, fatigue, peripheral neuropathy, hypercalcaemia and renal impairment. There remains a significant unmet need, particularly for patients who are heavily pre-treated, as the risk of relapse increases with each successive line of therapy. TALVEY is a bispecific antibody designed to bind to both myeloma cells and T cells. By redirecting T cells to the myeloma cells, the therapy activates an immune response that results in targeted tumour cell death. Under the final draft guidance, TALVEY may now be offered as a monotherapy for adults with RRMM following three or more lines of prior treatment, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody, where the disease has progressed on the most recent therapy. NICE’s recommendation is supported by data from the single-arm, open-label phase 1/2 MonumenTAL-1 study, which met both primary and secondary endpoints, demonstrating clinically meaningful responses across overall response rate, progression-free survival and overall survival. “Given the relapsing and remitting nature of multiple myeloma, patients can face a challenging care journey,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “People with myeloma need access to as many treatments as possible at every stage of their disease, and this is especially important at the later stages when options are more limited. “ Targeted medicines have the potential to help us get in front of cancer by delivering improved outcomes for patients versus standard of care therapies, and we look forward to today’s decision translating into uptake throughout England and Wales.”

iStock, Denis_prof The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that, until recently, accounted for 20% of innovative medicine sales. Johnson & Johnson has made a molehill out of a mountain. Facing the loss of exclusivity on a drug that accounted for 20% of innovative medicine sales in 2023, J&J has reshaped its business around other products and programs to leave analysts predicting a new era of growth for the company. The anticipated arrival of biosimilar versions of Stelara, J&J’s blockbuster autoimmune disease drug, has occupied analysts for years. J&J executives have fielded questions about their preparations since at least 2021, reflecting how important the anti-IL-12 and IL-23 antibody became to the company after sales of chronic inflammatory disease drug Remicade began to erode in the face of off-patent rivals. Stelara sales peaked at $10.9 billion in 2023. Biosimilar competition, first overseas and later in the U.S., caused sales to slip in 2024 and tumble further in 2025. Yet while sales of the drug fell 40% over the first nine months of 2025, J&J still grew global innovative medicine revenue by 5%. BioSpace , Annalee Armstrong Cutting and Investing The growth reflects J&J’s multi-year effort to adapt its business for a post-Stelara future. Some parts of the business have been sacrificed to enable investment in the most promising programs. In 2023, J&J axed clinical-phase programs targeting hepatitis B, HIV and respiratory syncytial virus and ended R&D at an infectious disease and vaccine site in the Netherlands. J&J CFO Joseph Wolk framed the infectious disease and vaccine changes in the context of Stelara at a Bernstein event in May; The company “probably had to cut some investment” to prepare for the entry of Stelara biosimilars, he said. J&J’s medtech business provides sales to offset slowdowns at the medicines unit but the company nonetheless had to pull back from some areas. “We still make choices. You saw last year we exited infectious diseases and vaccines. We still prioritize, but it gives us a lot more flexibility to manage for that long term and have the robust pipeline and the growth outlook we have for the balance of this decade,” Wolk said. As J&J pulled back from infectious diseases and vaccines, it invested in other areas to ensure new growth drivers were in place to ease the Stelara transition. At J&J’s immunology unit, rising sales of Tremfya and Simponi are partly offsetting the decline of Stelara and the development of icotrokinra , JNJ-4804 and nipocalimab are laying the groundwork for a potential new-look portfolio. All three assets are in development for multiple indications, from plaque psoriasis to ulcerative colitis to psoriatic arthritis. The emergence of oncology as J&J’s tentpole business has allowed the company to weather a period of falling immunology sales. Five years ago, J&J reported nine-month oncology revenue of $8.9 billion. Oncology sales for the first nine months of 2025 were $18.5 billion. The growth reflects the blossoming of multiple myeloma drug Darzalex, plus product launches. Darzalex was a blockbuster in 2020, generating sales of $2.9 billion in just the first nine months of the year. It has grown significantly since then. The growth covers a period in which J&J launched a subcutaneous version of Darzalex and expanded the label. Sales hit $10.4 billion over the first nine months of 2025. J&J has also turned its prostate cancer drug Erleada, which was approved in 2019, into a multi-billion dollar a year product. The CAR T cell therapy Carvykti became J&J’s latest cancer blockbuster in the third quarter of 2025, when total sales for the year reached $1.3 billion. With sales of the bispecific antibodies Tecvayli, Talvey and Rybrevant still rising, and the bladder cancer drug Inlexzo new to the market, J&J is aiming to grow oncology revenues to $50 billion by 2030. The forecast was at least three times above the 2028 analyst consensus estimate when the company made the prediction in July, partly reflecting J&J’s belief that annual Inlexzo sales will exceed $5 billion. Guggenheim Securities analysts recently discussed Inlexzo’s prospects with a community urologist. J&J could face competition from CG Oncology’s oncolytic immunotherapy cretostimogene grenadenorepvec. The urologist told the analysts that the ability to keep Inlexzo at room temperature, the lack of biohazard requirements and the option to administer the drug at the office give J&J an advantage. “The speaker emphasized that in his community practice setting, practical convenience and logistical advantages would be the main determinants in choosing between the two products,” the analysts wrote in a note to investors. “As such, he envisions using Inlexzo in the large majority of his patients when both products are available in the future.” Deals Drive Growth Speaking on an earnings call in October, J&J CEO Joaquin Duato called Inlexzo an example of the company’s “outstanding business development model.” J&J acquired the asset through its 2019 takeover of Taris Biomedical. Wolk said on the earnings call that the company paid “a couple of hundred million dollars” for Taris, which was then in early clinical development. Duato said J&J has completed “more than 60 deals of this kind” in the past 18 months. J&J has struck the early-stage deals alongside bigger bets such as its $14.6 billion takeover of Intra-Cellular Therapies. The deal added the schizophrenia and bipolar depression drug Caplyta to J&J’s neuroscience portfolio. Caplyta generated $240 million in the third quarter, helping J&J grow neuroscience revenues despite sales of Concerta and Invega falling. Spravato is the other key product in J&J’s neuroscience portfolio. Sales grew more than 50% to near $1.2 billion over the first nine months of 2025. The drugs have established neuroscience as J&J’s third biggest innovative medicine unit after oncology and immunology. J&J’s pulmonary hypertension and cardiovascular units also have blockbuster drugs, giving the company a broad base to offset future challenges. The nature of the pharma industry means new challenges are inevitable. J&J is now receiving questions about potential price negotiations and patent expirations for Darzalex. Guggenheim analysts said they believe investors are “underappreciating Darzalex’s increased longevity and potentially improved economics,” but at some point J&J will need to adapt to pressure on its latest star drug. Having navigated the launches of Remicade and Stelara biosimilars over the past decade, the company has established a track record of managing such pressures and continuing to grow.