Oncology · Small MoleculeTrial Updateclinicalmid-term

Deciphera's Vimseltinib Study Evaluates Interaction with Oral Contraceptives

The ongoing clinical trial evaluating vimseltinib's interaction with oral contraceptives is significant as it may influence prescribing practices and patient safety. The results could lead to changes in labeling, impacting the drug's market adoption and competitive positioning.

Importance7/ 10

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Deciphera Pharmaceuticals, LLC1 signalView page

AutoResearch

Multi-agent research across ingested FDA, EMA, MHRA, PMDA, PubMed, ClinicalTrials.gov, company documents, and Humanexa signals.

Last run 6/18/2026, 6:31:32 PM

Assessment confidence: 81% · The main uncertainty is whether clinical benefit translates into regulatory momentum and guideline influence.

Executive Thesis

Strategic Assessment

Results may inform labeling and usage guidelines for vimseltinib, affecting its adoption in clinical settings. The strongest clinical anchor is Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) (ClinicalTrials.gov), entity match (deciphera pharmaceuticals llc). In Oncology · Small Molecule, 0 regulatory and 4 competitive items passed relevance filtering for Deciphera Pharmaceuticals, LLC.

Competitive Pressure

The most relevant competitive pressure comes from FDA Grants Priority Review for Welireg Supplement NDA215383 (Humanexa Signals) — entity match (oncology). Secondary pressure from Phase III Study of Durvalumab + Domvanalimab in Stage III Unresectable NSCLC Initiated. Understanding drug interactions is crucial for patient safety and can influence prescribing practices, impacting Deciphera's market position.

Regulatory Outlook

Regulatory risk is concentrated around The findings may necessitate updates to vimseltinib's labeling and usage guidelines, which could impact its approval status and compliance with regulatory standards..

Key Risks

Elevated medium regulatory exposure for Deciphera Pharmaceuticals, LLC could delay market entry or constrain labeling if agency review intensifies.
Evidence gap: no medium- or high-relevance regulatory precedents in ingested corpus.

Key Opportunities

If the trial reveals significant interactions, it could affect vimseltinib's market share and revenue potential by altering how it is prescribed in clinical settings.
Oncology · NSCLC · Trial Update · These results position LORBRENA as a preferred standard of care over XALKORI in ALK-positive advanced NSCLC, potentially shifting treatment paradigms.
Upside for Deciphera Pharmaceuticals, LLC may improve if A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09) (ClinicalTrials.gov) delivers favorable follow-through.
Results may inform labeling and usage guidelines for vimseltinib, affecting its adoption in clinical settings.

What Would Change This Assessment

This becomes more urgent if Monitor for trial results and any subsequent changes to vimseltinib's prescribing information.
Timeline shift beyond mid term would change urgency.
A competitor label expansion or pivotal readout in the same sub-indication would increase competitive pressure.

Supporting Evidence

No evidence in this category.

Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
ClinicalTrials.govhigh relevance
Entity match (deciphera pharmaceuticals llc)
FDA document
View source
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
ClinicalTrials.govhigh relevance
Entity match (oncology)
FDA document
View source
Evaluation of Interactions and Group Processes in Multidisciplinary Tumor Boards in Gynecologic Oncology
ClinicalTrials.govhigh relevance
Entity match (oncology)
FDA document
View source
The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer
ClinicalTrials.govhigh relevance
Entity match (oncology)
FDA document
View source
A Study to Investigate the Effect of AZD6234, AZD9550, and Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Part
ClinicalTrials.govhigh relevance
Sponsor/company relevance (AstraZeneca)
FDA document
View source
A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.govhigh relevance
Moderate corpus alignment
FDA document
View source
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)
ClinicalTrials.govhigh relevance
Moderate corpus alignment
FDA document
View source
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)
ClinicalTrials.govmedium relevance
Moderate corpus alignment
FDA document
View source

FDA Grants Priority Review for Welireg Supplement NDA215383
Humanexa Signalshigh relevance
Entity match (oncology)
Phase III Study of Durvalumab + Domvanalimab in Stage III Unresectable NSCLC Initiated
Humanexa Signalshigh relevance
Entity match (oncology)
Pfizer's LORBRENA CROWN Trial Reports Longest Progression-Free Survival in Advanced NSCLC
Humanexa Signalshigh relevance
Entity match (oncology)
Study on Frailty in Young Adult Survivors of Childhood Cancer Highlights Long-term Health Risks
Humanexa Signalshigh relevance
Entity match (oncology)

Trial watch: antibody-drug conjugates in cancer therapy.
PubMedhigh relevance
Entity match (oncology)
FDA document
View source
Cost-effectiveness analysis of apixaban compared with other oral anticoagulants for the treatment of non-valvular atrial fibrillation in Belgian healthcare setting.
PubMedhigh relevance
Moderate corpus alignment
FDA document
View source
Potential implications of increased utilization of oral nirmatrelvir/ritonavir in outpatient care for COVID-19: modeled findings from the Spanish National Health System perspective.
PubMedhigh relevance
Moderate corpus alignment
FDA document
View source
In vitro screening of compounds for targeting gastric cancer with Y220C p53 mutation: a molecule combining zinc chelation and Michael acceptor drives CDKN1 and BBC3 expression to restore a p53-depende
PubMedhigh relevance
Moderate corpus alignment
FDA document
View source
Do subjective and objective baseline sleep disturbances predict post-traumatic stress disorder treatment response? A secondary analysis of a randomized controlled trial.
PubMedmedium relevance
Moderate corpus alignment
FDA document
View source
Oral self-assembly nanoemulsion drives in vivo hepatic stellate cell-targeting drug delivery in liver fibrosis.
PubMedmedium relevance
Moderate corpus alignment
FDA document
View source
Influencing factors of oral frailty in Chinese maintenance hemodialysis patients: Bayesian network analysis.
PubMedmedium relevance
Moderate corpus alignment
FDA document
View source

Regunera

Precedents · guidance

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Competitiva

Competitors · threats

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Why this matters

Affected entities

Deciphera Pharmaceuticals, LLC
Vimseltinib
Oncology

Commercial impact

medium

If the trial reveals significant interactions, it could affect vimseltinib's market share and revenue potential by altering how it is prescribed in clinical settings.

Regulatory impact

medium

The findings may necessitate updates to vimseltinib's labeling and usage guidelines, which could impact its approval status and compliance with regulatory standards.

What to watch

Monitor for trial results and any subsequent changes to vimseltinib's prescribing information.

Recommended action

Monitor

Track for follow-up milestones; no immediate action required.