- Approval Id
- fa67b9100c0b8a96
- Drug Approval Emc Name
- Pazopanib 200 mg film coated tablets
- Drug Name
- Pazopanib 200 mg film coated tablets
- Company Address
- First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
- Company Website
- https://www.zentiva.co.uk/contact/mi-form
- Company Medical Info Direct Line
- +44 (0)800 090 2408
- Company Medical Info Email
- [email protected]
- Company Customer Care Direct Line
- +44 (0)844 8793 188
- Atc Code
- L01EX03
- Legal Category
- Prescription only medicine
- Authorisation Holder
- 7. Marketing authorisation holder Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom
- Authorisation Number
- 8. Marketing authorisation number(s) PL 17780/1291
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 12/03/2025
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 17780/1291
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 12/03/2025
- Instruction Composition
- 2. Qualitative and quantitative composition Each film‑coated tablet contains 200 mg pazopanib (as hydrochloride). For the full list of excipients, see section 6.1
- Instruction Dosage Form
- 3. Pharmaceutical form Film‑coated tablet. Capsule-shaped, pink, film-coated tablet with “200” debossed on one side, with dimensions 1
- Instruction Clinical Particulars
- 4. Clinical particulars 4.1 Therapeutic indications Renal cell carcinoma (RCC) Pazopanib is indicated in adults for the first‑line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft‑tissue sarcoma (STS) Pazopanib is indicated for the treatment of adult patients with selective subtypes of advanced soft‑tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes (see section
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, other protein kinase inhibitors, ATC code: L01EX03 Mechanism of action Pazopanib is an orally administered, potent multi‑target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) ‑1, ‑2, and ‑3, platelet‑derived growth factor (PDGFR) ‑α and –β, and stem cell factor receptor (c‑KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively. In preclinical experiments, pazopanib dose‑dependently inhibited ligand‑induced auto‑phosphorylation of VEGFR‑2, c‑Kit and PDGFR‑β receptors in cells. In vivo, pazopanib inhibited VEGF‑induced VEGFR‑2 phosphorylation in mouse lungs, angiogenesis in various animal models, and the growth of multiple human tumour xenografts in mice. Pharmacogenomics In a pharmacogenetic meta‑analysis of data from 31 clinical studies of pazopanib administered either as monotherapy or in combination with other agents, ALT >5 x ULN (NCI CTC Grade 3) occurred in 19% of HLA‑B*57:01 allele carriers and in 10% of non‑carriers. In this dataset, 133/2235 (6%) of the patients carried the HLA‑B*57:01 allele (see section 4.4). Clinical studies Renal cell carcinoma (RCC) The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double‑blind, placebo‑controlled multicentre study. Patients (N = 435) with locally advanced and/or metastatic RCC were randomised to receive pazopanib 800 mg once daily or placebo. The primary objective of the study was to evaluate and compare the two treatment arms for progression‑free survival (PFS) and the principle secondary endpoint was overall survival (OS). The other objectives were to evaluate the overall response rate and duration of response. From the total of 435 patients in this study, 233 patients were treatment‑naïve and 202 were second‑line patients who had received one prior IL‑2 or INFα‑based therapy. The performance status (ECOG) was similar between the pazopanib and placebo groups (ECOG 0: 42% vs. 41%, ECOG 1: 58% vs. 59%). The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors. All patients had clear cell histology or predominantly clear cell histology. Approximately half of all patients had 3 or more organs involved in their disease and most patients had the lung (74%), and/or lymph nodes (54%) as a metastatic location for disease at baseline. A similar proportion of patients in each arm were treatment‑naïve and cytokine pre‑treated (53% and 47% in pazopanib arm, 54% and 46% in placebo arm). In the cytokine pre‑treated subgroup, the majority (75%) had received interferon‑based treatment. Similar proportions of patients in each arm had prior nephrectomy (89% and 88% in the pazopanib and placebo arms, respectively) and/or prior radiotherapy (22% and 15% in the pazopanib and placebo arms, respectively. The primary analysis of the primary endpoint PFS is based on disease assessment by independent radiological review in the entire study population (treatment‑naïve and cytokine pre‑treated). Table 4 Overall efficacy results in RCC by independent assessment (VEG105192) Endpoints/Study population Pazopanib Placebo HR (95% CI) P value (one‑sided) PFS Overall* ITT Median (months) N = 290 9.2 N = 145 4.2 0.46 (0.34, 0.62) <0.0000001 Response rate % (95% CI) N = 290 30 (25.1,35.6) N = 145 3 (0.5,
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Tablet core Microcrystalline cellulose Sodium starch glycolate (type A) Povidone (K30) Magnesium stearate Tablet coating Hypromellose Macrogol 400 Polysorbate 80 Titanium dioxide (E171) Iron oxide red (E172) 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Clear/transparent Aluminium-PVC/PE/PVDC blisters or white HDPE bottles with polypropylene child resistant cap. Pack size: Blisters 30, 90, 30x1, 90,x multipack 90 (3 packs of 30), multipack 90 (3 packs of 30x1) tablets. Bottles: 30, 90 or multipack 90 (3 packs of 30 tablets) Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling No special requirements.
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Each film‑coated tablet contains 200 mg pazopanib (as hydrochloride). For the full list of excipients, see section 6.1
## Pharmaceutical Form
3. Pharmaceutical form Film‑coated tablet. Capsule-shaped, pink, film-coated tablet with “200” debossed on one side, with dimensions 1
## Clinical Particulars
4. Clinical particulars 4.1 Therapeutic indications Renal cell carcinoma (RCC) Pazopanib is indicated in adults for the first‑line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft‑tissue sarcoma (STS) Pazopanib is indicated for the treatment of adult patients with selective subtypes of advanced soft‑tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes (see section
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, other protein kinase inhibitors, ATC code: L01EX03 Mechanism of action Pazopanib is an orally administered, potent multi‑target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) ‑1, ‑2, and ‑3, platelet‑derived growth factor (PDGFR) ‑α and –β, and stem cell factor receptor (c‑KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively. In preclinical experiments, pazopanib dose‑dependently inhibited ligand‑induced auto‑phosphorylation of VEGFR‑2, c‑Kit and PDGFR‑β receptors in cells. In vivo, pazopanib inhibited VEGF‑induced VEGFR‑2 phosphorylation in mouse lungs, angiogenesis in various animal models, and the growth of multiple human tumour xenografts in mice. Pharmacogenomics In a pharmacogenetic meta‑analysis of data from 31 clinical studies of pazopanib administered either as monotherapy or in combination with other agents, ALT >5 x ULN (NCI CTC Grade 3) occurred in 19% of HLA‑B*57:01 allele carriers and in 10% of non‑carriers. In this dataset, 133/2235 (6%) of the patients carried the HLA‑B*57:01 allele (see section 4.4). Clinical studies Renal cell carcinoma (RCC) The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double‑blind, placebo‑controlled multicentre study. Patients (N = 435) with locally advanced and/or metastatic RCC were randomised to receive pazopanib 800 mg once daily or placebo. The primary objective of the study was to evaluate and compare the two treatment arms for progression‑free survival (PFS) and the principle secondary endpoint was overall survival (OS). The other objectives were to evaluate the overall response rate and duration of response. From the total of 435 patients in this study, 233 patients were treatment‑naïve and 202 were second‑line patients who had received one prior IL‑2 or INFα‑based therapy. The performance status (ECOG) was similar between the pazopanib and placebo groups (ECOG 0: 42% vs. 41%, ECOG 1: 58% vs. 59%). The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors. All patients had clear cell histology or predominantly clear cell histology. Approximately half of all patients had 3 or more organs involved in their disease and most patients had the lung (74%), and/or lymph nodes (54%) as a metastatic location for disease at baseline. A similar proportion of patients in each arm were treatment‑naïve and cytokine pre‑treated (53% and 47% in pazopanib arm, 54% and 46% in placebo arm). In the cytokine pre‑treated subgroup, the majority (75%) had received interferon‑based treatment. Similar proportions of patients in each arm had prior nephrectomy (89% and 88% in the pazopanib and placebo arms, respectively) and/or prior radiotherapy (22% and 15% in the pazopanib and placebo arms, respectively. The primary analysis of the primary endpoint PFS is based on disease assessment by independent radiological review in the entire study population (treatment‑naïve and cytokine pre‑treated). Table 4 Overall efficacy results in RCC by independent assessment (VEG105192) Endpoints/Study population Pazopanib Placebo HR (95% CI) P value (one‑sided) PFS Overall* ITT Median (months) N = 290 9.2 N = 145 4.2 0.46 (0.34, 0.62) <0.0000001 Response rate % (95% CI) N = 290 30 (25.1,35.6) N = 145 3 (0.5,
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Tablet core Microcrystalline cellulose Sodium starch glycolate (type A) Povidone (K30) Magnesium stearate Tablet coating Hypromellose Macrogol 400 Polysorbate 80 Titanium dioxide (E171) Iron oxide red (E172) 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Clear/transparent Aluminium-PVC/PE/PVDC blisters or white HDPE bottles with polypropylene child resistant cap. Pack size: Blisters 30, 90, 30x1, 90,x multipack 90 (3 packs of 30), multipack 90 (3 packs of 30x1) tablets. Bottles: 30, 90 or multipack 90 (3 packs of 30 tablets) Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling No special requirements.
- Company Detail Path
- /organization/sanofi-ilac-sanayi-ve-ticaret-anonim-sirketi
