Poziotinib

Overview

Poziotinib has been used in trials studying the treatment of Breast Cancer, Metastatic Breast Cancer, Increased Drug Resistance, Adenocarcinoma of Lung Stage IV, and Adenocarcinoma of Lung Stage IIIB, among others.

Indication

用于治疗非小细胞肺癌、乳腺癌和胃癌。对于吉非替尼和厄洛替尼耐药性EGFR L858R/T790M双突变细胞有很强的抑制作用。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations	2022/05/18	NCT05378763	Phase 3	Suspended	Spectrum Pharmaceuticals, Inc
Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer	2021/09/16	NCT05045404	Phase 2	Withdrawn	M.D. Anderson Cancer Center
A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants	2021/07/29	NCT04981704	Phase 1	Completed	Spectrum Pharmaceuticals, Inc
Study of Poziotinib in Japanese Patients With NSCLC	2020/05/26	NCT04402008	Phase 1	Terminated	Spectrum Pharmaceuticals, Inc
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies	2019/11/21	NCT04172597	Phase 2	Terminated	Spectrum Pharmaceuticals, Inc
Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation	2019/08/05	NCT04044170	Phase 2	Terminated	Hanmi Pharmaceutical Company Limited
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib	2019/01/15	NCT03804515	Phase 1	Terminated	Spectrum Pharmaceuticals, Inc
A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)	2018/12/10	NCT03770988	Phase 2	UNKNOWN	Yonsei University
A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib	2018/11/16	NCT03744715	Phase 2	Terminated	Spectrum Pharmaceuticals, Inc
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer	2018/02/12	NCT03429101	Phase 1	Terminated	Spectrum Pharmaceuticals, Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

FDA Rejects Poziotinib for HER2-Mutated NSCLC Following Advisory Committee's Negative Vote

5 months ago

• The FDA has issued a complete response letter for poziotinib, Spectrum Pharmaceuticals' pan-HER2 inhibitor, rejecting its application for HER2 exon 20 insertion-mutated non-small cell lung cancer treatment. • The rejection follows a 9-4 vote against approval by FDA's Oncologic Drugs Advisory Committee, citing concerns over marginal efficacy, high toxicity rates, and delayed confirmatory trials. • Phase 2 ZENITH20 study showed limited efficacy with 28% objective response rate and five-month median response duration, while 12% of patients discontinued due to adverse effects.

Advancements in HER2-Mutant NSCLC Therapies: A Pipeline Overview

10 months ago

Several companies are actively developing novel therapies for HER2-mutant non-small cell lung cancer (NSCLC), indicating a robust pipeline.

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