{"id":"pf-07104091-monotherapy-dose-expansion-ovarian","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Aspirin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"P2Y12 inhibitors","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Anticoagulants","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antiplatelet agents","action":"Monitor","effect":"Increased risk of bleeding"}],"commonSideEffects":[],"contraindications":["Other medical or psychiatric condition","Serum pregnancy test positive at screening","Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic","Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers","Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).","Previous high dose chemotherapy requiring stem cell rescue","Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally","Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short","Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.","Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.","Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry.","Hypertension that cannot be controlled by medications","Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.","Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease.","Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or","Active COVID-19/SARS-CoV2 infection","Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or","Prior irradiation to >25% of the bone marrow","Systemic anti cancer therapy within 4 weeks prior to study","Radiation therapy within 3 weeks prior to study entry.","Major surgery within 3 weeks prior to study entry","Participants with known symptomatic brain metastases requiring steroids"],"specialPopulations":{"Pregnancy":"Serum pregnancy test positive at screening is an exclusion criterion.","Geriatric use":"text","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=pf-07104091-monotherapy-dose-expansion-ovarian","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:47:07.126504+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:47:13.613212+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:47:07.203373+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=pf-07104091-monotherapy-dose-expansion-ovarian","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:47:13.963135+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5201870/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:47:15.055949+00:00"}},"allNames":"pf-07104091 monotherapy dose expansion (ovarian)","offLabel":[],"timeline":[],"aiSummary":"PF-07104091 is a marketed drug by Pfizer Inc. for advanced ovarian cancer. It is a small molecule with a novel mechanism. The drug has shown significant commercial success with $21.2B in revenue. PF-07104091 is a first-in-class treatment for its indication. It has one ongoing trial. There are no publications available for this drug. The drug's mechanism is not well-documented on Wikipedia.","brandName":"PF-07104091 monotherapy dose expansion (ovarian)","ecosystem":[],"isGeneric":true,"mechanism":{"target":"[insert molecular target]","novelty":"first-in-class","modality":"small molecule","drugClass":"small molecule","explanation":"","oneSentence":"","technicalDetail":"PF-07104091 is a small molecule inhibitor that targets the [insert molecular target] pathway. This pathway is involved in the regulation of cell growth and proliferation, and its dysregulation is a common feature of cancer. By inhibiting this pathway, PF-07104091 is able to slow or stop the growth of cancer cells."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"yoyGrowth":"7%","revenueYear":2025,"annualCostUS":"$80,000/yr","annualRevenue":798,"genericStatus":"Generic — off-patent","revenueSource":"SEC 8-K Bristol-Myers Squibb (2026-02-05)","currentRevenue":"$21.2B","revenueCurrency":"USD","peakSalesEstimate":"$21.2B","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:47:02.606798","revenueExtractedBy":"revenue-sec"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=pf-07104091-monotherapy-dose-expansion-ovarian","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=pf-07104091-monotherapy-dose-expansion-ovarian","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":4,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:16.734123+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"palbociclib","company":"Industry","advantage":"Competes with PF-07104091 in combination therapy for ovarian cancer"},{"name":"fulvestrant","company":"Industry","advantage":"Competes with PF-07104091 in combination therapy for ovarian cancer"},{"name":"letrozole","company":"Industry","advantage":"Competes with PF-07104091 in combination therapy for ovarian cancer"},{"name":"PF-0704091","company":"Industry","advantage":"Competes with PF-07104091 in combination therapy for ovarian cancer"}],"genericName":"pf-07104091-monotherapy-dose-expansion-ovarian","indications":{"approved":[{"name":"Advanced ovarian cancer","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04553133","phase":"PHASE2","title":"PF-07104091 as a Single Agent and in Combination Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2020-09-16","conditions":"Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer","enrollment":154}],"_emaApprovals":[{"date":"","name":"PF-07104091 monotherapy dose expansion (ovarian)","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL5201870"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Oncology"],"_revenueScrapedAt":"2026-04-01 10:47:02.629581+00","biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":3,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:16.734123+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}