Sotorasib bulk supplier for pharma manufacturers

Sotorasib 120 mg, 240 mg, 320 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 120 mg, 240 mg, 320 mg

Reference Brands: Lumakras (USA/EU)

Sotorasib (Lumakras) is used to treat adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. It works by selectively inhibiting the KRAS G12C protein, preventing cancer cell growth and proliferation, and thereby slowing disease progression.

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Product Description:

Sotorasib was the first drug to hit KRAS, a target considered undruggable for forty years. KRAS has no deep pocket for a small molecule to occupy, and it binds its natural partner GTP so tightly that competing is hopeless. The G12C mutation happens to introduce a cysteine residue next to a shallow groove that only appears when the protein is briefly in its off state. Sotorasib slips into that groove and bonds to the cysteine permanently, locking the protein off.

It is used for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer after at least one prior systemic therapy, and, combined with the EGFR antibody panitumumab, for KRAS G12C-mutated metastatic colorectal cancer, where EGFR feedback otherwise blunts the effect. Diarrhoea, nausea, fatigue and musculoskeletal pain are common. Hepatotoxicity is the significant risk, more frequent when given close to immunotherapy, and liver function requires regular monitoring.

Sourcing notes. Originator product, on patent. The 960 mg daily dose can be made up from 120, 240 or 320 mg tablets, so quantities must be calculated per day and the tablet strength specified. Requires KRAS G12C testing at the destination — a market without that assay cannot use it. Acid-reducing drugs interfere with absorption. Room temperature.

How Sotorasib is supplied today, and licensing ahead of patent expiry

Sotorasib is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Sotorasib, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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Frequently Asked Questions

Sotorasib is used to treat non-small cell lung cancer (NSCLC) with KRAS G12C mutations in patients who have received prior therapies.

Sotorasib is a small-molecule inhibitor that selectively targets the KRAS G12C mutant protein, blocking cancer cell growth.

The trade name is Lumakras.

Lumakras is manufactured by Amgen.

The generic name is sotorasib.

The brand name is Lumakras.

It is manufactured in the United States by Amgen.

Sotorasib is sold as Lumakras and Lumykras. It is developed and sold by Amgen. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.