drug · small molecule
sotorasib
Marketedupdated 5mo agoby $AMGN AMGEN INC🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neoplasm and non-small cell lung carcinoma and 4 investigational indications.
indications
investigational
NSCLC
targets
GTPase KRas
all catalysts(0)
nothing on the calendar yet
Trials studying sotorasib
- phase3A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
- phase3A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
- phase2A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)
- phase3Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
- phase1Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
- phase2A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
- phase1Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors
- —Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 16, 2028
~1.3 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (18)
- Sep 15, 2040method-of-use (U-4107)US 11426404
- Sep 15, 2040method-of-use (U-3306)US 11426404
- Sep 15, 2040method-of-use (U-4107)US 11426404
- May 20, 2040compositionUS 11236091
- May 20, 2040compositionUS 11236091
- May 20, 2040compositionUS 11236091
- May 20, 2040compositionUS 11827635
- May 20, 2040compositionUS 11827635
- May 20, 2040compositionUS 11827635
- May 20, 2040compositionUS 12398133
- May 20, 2040compositionUS 12398133
- May 20, 2040compositionUS 12398133
- Nov 18, 2039method-of-use (U-4107)US 12280056
- Nov 18, 2039method-of-use (U-4107)US 12280056
- Nov 18, 2039method-of-use (U-4107)US 12280056
- May 21, 2038compositionUS 10519146
- May 21, 2038compositionUS 10519146
- May 21, 2038compositionUS 10519146
FDA exclusivities (12)
- Jan 16, 2032ODE-507Orphan Drug (7y)
- Jan 16, 2032ODE-507Orphan Drug (7y)
- Jan 16, 2032ODE-507Orphan Drug (7y)
- May 28, 2028ODE-352Orphan Drug (7y)1.6y
- May 28, 2028ODE-352Orphan Drug (7y)1.6y
- May 28, 2028ODE*ODE*1.6y
- Jan 16, 2028I-962Indication (3y)1.3y
- Jan 16, 2028I-962Indication (3y)1.3y
- Jan 16, 2028I-962Indication (3y)1.3y
- May 28, 2026NCENew Chemical Entity (5y)
- May 28, 2026NCENew Chemical Entity (5y)
- May 28, 2026NCENew Chemical Entity (5y)
News(5)
- FDA delays approval decision for Exelixis' tyrosine kinase inhibitor in colorectal cancerThe FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor in combination with Roche’s Tecentriq for the treatment of metastatic colorectal cancer.fiercebiotech · 22d ago
- After some ‘tough years,’ Frontier’s CEO is ramping up ambitions for precision med platformAfter announcing the “tough but necessary” decision to lay off some employees last year, Frontier Medicines is looking to the future by advancing more cancer drugs into the clinic while continuing…fiercebiotech · 1mo ago
- UK price watchdog recommends against Amgen's Lumakras in lung cancerThe UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institute…endpoints · 2mo ago
- STAT+: Does Revolution Medicines’ pancreatic cancer drug have even greater potential?Revolution Medicines' pancreatic cancer drug has not yet been approved — and already talk has shifted to how (and when) its use might be expanded.stat · 4mo ago
- ‘Unprecedented’ Revolution data point to paradigm shift in pancreatic cancerHighly anticipated data presented at ASCO confirmed what’s been heralded as a medical breakthrough against a historically tough-to-treat tumor.biopharma_dive · 4mo ago
Data sources
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