Lutetium Lu-177 vipivotide tetraxetan
- Generic Name
- Lutetium Lu-177 vipivotide tetraxetan
- Brand Names
- Pluvicto
- Drug Type
- Small Molecule
- Chemical Formula
- C49H68LuN9O16
- CAS Number
- 1703749-62-5
- Unique Ingredient Identifier
- G6UF363ECX
- Background
Lutetium Lu-177 vipivotide tetraxetan is a radioligand therapeutic agent. It consists of a radionuclide, lutetium Lu-177, linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer.
Lutetium Lu-177 vipivotide tetraxetan was first approved by the FDA on March 23, 2022 as a treatment for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended lutetium Lu-177 vipivotide tetraxetan be granted marketing authorization for the treatment of prostate cancer. In December 2022, lutetium Lu-177 vipivotide tetraxetan was approved by the EMA.
- Indication
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
- Associated Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC), Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Associated Therapies
- -
Integration of Lutetium Lu 177 Vipivotide Tetraxetan Highlights Potential of Radioligands in ...
The FDA's approval of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in 2022 has significantly impacted the treatment of prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC). This radioligand therapy, after other treatments like ARPIs and taxane-based chemotherapy, has shown life-prolonging effects and improved quality of life. Potential future applications include earlier use in the treatment paradigm and combination therapies, with ongoing research aiming to establish a broader role for this treatment type.
Related Clinical Trials:
Nicole M. Maughan, PhD, receives SNMMI Mars Shot Fund Award
Nicole M. Maughan, PhD, receives $100,000 SNMMI Mars Shot Fund award for establishing a centralized dosimetry process with peripheral SPECT/CT image acquisition in radiopharmaceutical therapy, aiming to improve personalized treatment in community practices.
Precision Medicine for Prostate Cancer: The Role of Radiopharmaceuticals
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.
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Convergent Therapeutics: $40 Million (Series A Extension) Secured From Novo
Convergent Therapeutics announced the first patient dosed with CONV01-α in the Phase II CONVERGE-01 trial for PSMA PET-positive mCRPC, and a $40 million Series A extension by Novo Holdings, increasing the total Series A raise to $130 million. Jim Trenkle, PhD, joins the Convergent Board of Directors. The CONVERGE-01 trial is designed to assess CONV01-α's safety and efficacy in mCRPC patients. Richard Messmann, MD, MHS, MSc, joins as Chief Medical Officer, bringing 25+ years of oncology drug development experience.
CellBion eyes global expansion in radiopharmaceuticals after Kosdaq IPO
CellBion, a Korean developer of radioisotope-based cancer therapeutics, plans global growth post-Kosdaq listing, focusing on new radiopharmaceutical treatments for prostate cancer and international technology exports. Its Lu-177-DGUL targets metastatic castration-resistant prostate cancer (mCRPC) with phase 2 trials showing superior efficacy and safety compared to Novartis' Pluvicto. The company aims to complete phase 2 trials in H1 2024, pursue conditional approval for early launch, and expand globally through partnerships and patent registrations.
We will lead the radiopharmaceutical market with the launch of new prostate cancer drugs
Cellvion CEO Kim Kwon announces plans for IPO on KOSDAQ, focusing on Lu-177-DGUL, a prostate cancer treatment with superior objective response rate and fewer side effects compared to Novartis' Pluvicto. The drug, set for early release in October next year, targets a 7.4% market share with a product price of 27 million won, aiming for 42.9 billion won in sales by 2027. General subscription for the IPO is scheduled for the 7th to 8th of next month.
Phase 3 Study Shows Viability of 177Lu-PSMA-617 for Taxane-Naïve Metastatic Castration
In a phase 3 trial, 177Lu-PSMA-617 showed longer median radiographic progression-free survival (11.6 months vs. 5.59 months) and higher PSA response (51% vs. 17%) compared to ARPI therapy change in taxane-naïve mCRPC patients, with a favorable safety profile.
UpFrontPSMA: 177Lu-PSMA-617 shows potential in mHSPC
177Lu-PSMA-617 plus docetaxel improved outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) without increased toxicity compared to docetaxel alone, according to the phase 2 UpFrontPSMA study. The addition of lutetium-PSMA to docetaxel significantly improved undetectable PSA levels at 48 weeks and multiple secondary endpoints with no increase in overall toxicity.
Eli Lilly brings the competition to Novartis with new results in mCRPC
Eli Lilly’s 177Lu-PNT2002, compared to ARPIs like Xtandi and Zytiga, showed efficacy in mCRPC patients positive for PSMA at ESMO 2024. Despite initial negative OS results, crossover adjustments led to a favorable HR of 0.68, likely influencing FDA approval. 177Lu-PNT2002, with lower dosage and fewer cycles than Pluvicto, may challenge Novartis’s market position.
Drug Development Updates
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