drug · small molecule
entrectinib
Marketedupdated 3mo agoby F. Hoffmann-La Roche Ltd🔗 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 6 investigational indications.
indications
investigational
NSCLC
targets
ALK tyrosine kinase receptorNeurotrophic tyrosine kinase receptorProto-oncogene tyrosine-protein kinase ROS
all catalysts(0)
nothing on the calendar yet
Trials studying entrectinib
- phase3A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
- phase2Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- phase2A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
- phase2Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
- phase1Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
- phase2Genetic Testing in Guiding Treatment for Patients With Brain Metastases
- phase2Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
- phase3A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 20, 2026
60 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (28)
- Jul 18, 2038formulationUS 10398693
- Jul 18, 2038formulationUS 10398693
- Jul 18, 2038formulationUS 11253515
- Jul 18, 2038formulationUS 11253515
- May 18, 2037compositionUS 10738037
- May 18, 2037compositionUS 10738037
- May 18, 2037method-of-use (U-2618)US 11091469
- May 18, 2037method-of-use (U-2618)US 11091469
- Feb 19, 2035method-of-use (U-2745)US 10561651
- Feb 19, 2035method-of-use (U-2745)US 10561651
- Feb 17, 2035method-of-use (U-2617)US 10231965
- Feb 17, 2035method-of-use (U-2617)US 10231965
- May 22, 2033compositionUS 9085565
- May 22, 2033compositionUS 9085565
- May 22, 2033method-of-use (U-2617)US 9649306
- May 22, 2033method-of-use (U-2617)US 9649306
- Mar 10, 2032compositionUS 8299057
- Mar 10, 2032compositionUS 8299057
- Jul 8, 2028method-of-use (U-2617)US 86738931.9y
- Jul 8, 2028method-of-use (U-2617)US 86738931.9y
- Jul 8, 2028compositionUS 90293561.9y
- Jul 8, 2028compositionUS 90293561.9y
- Jul 8, 2028formulationUS 90855581.9y
- Jul 8, 2028formulationUS 90855581.9y
- Jul 8, 2028method-of-use (U-2617)US 92550871.9y
- Jul 8, 2028method-of-use (U-2617)US 92550871.9y
- Jul 8, 2028method-of-use (U-2618)US 96160591.9y
- Jul 8, 2028method-of-use (U-2618)US 96160591.9y
FDA exclusivities (11)
- Oct 20, 2030ODE-448Orphan Drug (7y)4.2y
- Oct 20, 2030ODE-448Orphan Drug (7y)4.2y
- Oct 20, 2030ODE-448Orphan Drug (7y)4.2y
- Oct 20, 2026NPPNew Product (3y)60d
- Oct 20, 2026NPPNew Product (3y)60d
- Oct 20, 2026NPNP60d
- Aug 15, 2026ODE-313Orphan Drug (7y)
- Aug 15, 2026ODE-313Orphan Drug (7y)
- Aug 15, 2026ODE-265Orphan Drug (7y)
- Aug 15, 2026ODE*ODE*
- Aug 15, 2026ODE-265Orphan Drug (7y)
News(1)
- GSK lung cancer drug gets speedy approval following $10.6B dealThe clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.biopharma_dive · 29d ago
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