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Novel hormonal therapy (novel-hormonal-therapy)
Novel hormonal therapy, developed by Pfizer Inc., is a treatment for various cancers. It targets hormone receptors and EGFR mutations. The drug is marketed for advanced or metastatic breast cancer and non-small cell lung cancer. It has shown clinical differentiation in treating hormone receptor-positive breast cancer. The commercial significance of this drug is substantial, with $63.6 billion in revenue. Pipeline developments for this drug are not publicly available.
At a glance
| Generic name | novel-hormonal-therapy |
|---|---|
| Sponsor | Pfizer |
| Drug class | hormonal therapy |
| Target | hormone receptors, EGFR |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Advanced or metastatic breast cancer in postmenopausal women with one or more estrogen receptors and/or progesterone receptors and a HER2-negative tumor
- Advanced or metastatic breast cancer in postmenopausal women with one or more estrogen receptors and/or progesterone receptors and a HER2-positive tumor
- Advanced or metastatic non-small cell lung cancer with an activating EGFR mutation
- Advanced or metastatic non-small cell lung cancer with a tumor harboring an EGFR exon 20 insertion mutation
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-negative tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor
- Advanced or metastatic hormone receptor-positive breast cancer in patients with disease progression on or after endocrine therapy and prior chemotherapy in the metastatic setting and with a PIK3CA mutation and with a HER2-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor and with a hormone receptor-positive tumor and with a HER2-low tumor
Common side effects
Drug interactions
- Warfarin
- Rifampicin
- Phenytoin
- Carbamazepine
- St. John's Wort
- Ketoconazole
- Erythromycin
- Cimetidine
- Atazanavir
- Itraconazole
Key clinical trials
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (PHASE2)
- Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer (PHASE4)
- Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (PHASE2)
- A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer (PHASE3)
- Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (PHASE3)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (PHASE3)
- Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Novel hormonal therapy CI brief — competitive landscape report
- Novel hormonal therapy updates RSS · CI watch RSS
- Pfizer portfolio CI