Lutetium Lu-177

Radiopharmaceuticals are crucial in advanced prostate cancer treatment, delivering radiation directly to cancer cells. PSMA imaging enhances detection of disease spread. Radiopharmaceuticals like radium-223 and lutetium-177 are used in metastatic cases post-androgen deprivation therapy. Emerging alpha emitters like actinium-225 show promise. Challenges include earlier disease stage use and widespread access. Combining radiopharmaceuticals with other therapies and improving access are key unmet needs.

EMA's CHMP recommended approval for 8 new medicines and extended indications for 12 others, including treatments for cancers, hemophilia, meningococcus, and biosimilars for age-related macular degeneration. Updates to COVID-19 vaccines Spikevax and Comirnaty targeting new variants were also recommended. CHMP extended indications for mpox vaccine Imvanex and others, while refusing authorization for Syfovre. Bruno Sepodes was elected as new CHMP chair, prioritizing medicine quality, safety, and efficacy.

EMA's CHMP recommended approval for 8 new medicines and extended indications for 12 drugs, including treatments for cancers, hemophilia, meningococcus, and biosimilars for age-related macular degeneration. CHMP also updated COVID-19 vaccines Spikevax and Comirnaty to target new variants. Bruno Sepodes was elected as the new CHMP chair, prioritizing medicine quality, safety, and efficacy.

The Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair, effective 21 September. CHMP recommended marketing authorisations for eight new medicines, including Elahere, Hetronifly, Hympavzi, Penbraya, Theralugand, Afqlir, Opuviz, and Pomalidomide Teva. It also recommended extending indications for 12 existing medicines and confirmed the refusal of Syfovre's marketing authorisation. Applications for Durysta, Tecentriq, and Sialanar were withdrawn. CHMP updated Spikevax and Comirnaty vaccines to target new COVID-19 variants.

Peter Macallum Cancer Centre's UpFrontPSMA study shows LuPSMA therapy significantly improves outcomes for newly diagnosed prostate cancer patients, with 41% achieving undetectable PSA at 48 weeks compared to 16% with standard-of-care. The results were published in *Lancet Oncology* and presented at ESMO 2024.

The Lutetium-177 market, valued at USD 167.7 million in 2023, is projected to grow at a CAGR of 21.44% to USD 653.53 million by 2030, driven by its use in cancer treatment and the rise in cancer incidence. Non-carrier-added Lu-177, due to its higher purity, is gaining traction for targeted therapies, reducing side effects and radioactive waste. Key applications include treating neuroendocrine tumors and prostate cancer, with ongoing research exploring its potential in other medical areas. Market growth is supported by technological advancements in radiopharmaceuticals, increased government healthcare funding, and an aging population, though challenges include stringent regulations and high production costs.

Theranostics, precision medicine using PET imaging to identify targets for therapy, has evolved rapidly in nuclear medicine. Examples include 18F-FGFR1 for FGFR1-expressing tumors, 89Zr-girentuximab for hypoxia imaging, and PSMA-targeted radiotracers for ccRCC. Clinical applications like PSMA-targeted theranostics in non-prostate cancers and individualized dosimetry with lutetium-177-labeled agents are discussed. The potential of digital twins for personalized dosing is also highlighted, emphasizing the need for continued research and technological advancements.