Lutetium Lu-177

Novartis Q3 2024 results: net sales +10% (cc, +9% USD), core operating income +20% (cc, +17% USD), driven by strong performance from Entresto, Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio. Operating income +123% (cc, +106% USD), net income +121% (cc, +111% USD), core EPS +20% (cc, +18% USD) to USD 2.06. Free cash flow USD 6.0 billion (+18% USD). Full-year 2024 guidance raised: net sales expected to grow low double-digit, core operating income high teens.

Prostate cancer stages include localized, locally advanced, non-metastatic castration-resistant (M0 CRPCa), and metastatic disease. Treatments for M0 CRPCa and hormone-naive metastatic prostate cancer include androgen deprivation therapy with apalutamide, darolutamide, or enzalutamide. Metastatic castration-resistant treatments include sipuleucel-T, radium-223, abiraterone, enzalutamide, and cabazitaxel. New drugs like PARP inhibitors and Lutetium-177 aim to improve survival and progression-free survival, with ongoing trials for cabozantinib and chimeric-antigen receptor T-cell therapy.

MU expands NCA Lu-177 production for cancer therapies, solidifying MURR's role as the sole U.S. producer and a leader in radiopharmaceutical production.

TUM, TUM University Hospital, and ITM sign research agreement to enhance collaboration in nuclear medicine, radiopharmacy, and medical isotope technology, aiming to develop targeted cancer therapies using FRM II research reactor and ITM’s radiopharmaceutical expertise.

Companies are developing radiolabeled antibody-drug conjugates (rADCs) to target cancer cells directly, reducing side effects and treatment times. rADCs, which use antibodies to deliver radiation to cancer cells, are seen as an emerging modality in oncology. Despite challenges like supply and delivery hurdles, clinical trials are progressing, with promising interim results and FDA orphan drug designations.

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.