Neratinib
- Generic Name
- Neratinib
- Brand Names
- Nerlynx
- Drug Type
- Small Molecule
- Chemical Formula
- C30H29ClN6O3
- CAS Number
- 698387-09-6
- Unique Ingredient Identifier
- JJH94R3PWB
- Background
Neratinib was approved in July 2017 for use as an extended adjuvant therapy in Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer. Approval was granted to Puma Biotechnology Inc. for the tradename Nerlynx. Neratinib is currently under investigation for use in many other forms of cancer.
- Indication
For use as an extended adjuvant treatment in adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy [FDA Label].
- Associated Conditions
- Breast Cancer
Er-Kim and Puma Biotechnology Partner to Bring NERLYNX to Eastern Europe and Central Asia for HER2-Positive Breast Cancer Patients
• Er-Kim has signed an exclusive distribution agreement with Puma Biotechnology to commercialize NERLYNX (neratinib) in ten countries across Eastern Europe and Central Asia, expanding access to this targeted HER2 therapy.
• NERLYNX is approved for early-stage HER2-positive breast cancer patients previously treated with trastuzumab-based therapy, as well as for metastatic HER2-positive breast cancer in combination with capecitabine.
• The partnership addresses significant regional disparities in breast cancer treatment availability, with breast cancer being the most common cancer among women globally, affecting 2.3 million new patients in 2022.
Puma Biotechnology Advances Clinical Development of Alisertib in Lung and Breast Cancer
• Puma Biotechnology has launched two Phase II clinical trials for alisertib, targeting extensive-stage small cell lung cancer as monotherapy and HER2-negative HR-positive metastatic breast cancer in combination with endocrine therapy.
• The company's expansion into alisertib development follows their success with NERLYNX (neratinib), which is FDA-approved for HER2-positive breast cancer in both early-stage and metastatic settings.
• Alisertib, an oral aurora kinase A inhibitor, represents Puma's strategic expansion in oncology, with the company securing exclusive development and commercialization rights in September 2022.
Puma Biotechnology Acquires Takeda's Aurora Kinase Inhibitor Alisertib for $7M Upfront
• Puma Biotechnology has acquired rights to alisertib from Takeda for $7 million upfront, with potential milestone payments of $287 million plus royalties.
• The aurora kinase A inhibitor will be developed for multiple cancer indications, including hormone receptor-positive breast cancer, triple-negative breast cancer, and small cell lung cancer.
• Despite previous setbacks in lymphoma trials, alisertib has shown promising anti-tumor activity both as monotherapy and in combination with other anticancer drugs.
FDA Grants Priority Review to Boehringer's Zongertinib for HER2-Mutant Advanced Lung Cancer
• Boehringer Ingelheim's zongertinib could become the first oral targeted therapy for previously treated HER2-mutant advanced non-small cell lung cancer, with FDA decision expected in Q3 2025.
• Phase Ib trial demonstrated impressive 71% objective response rate in 75 previously treated NSCLC patients, with favorable safety profile and low treatment discontinuation rate.
• The drug addresses a significant unmet need in HER2-mutant NSCLC patients, who currently face poor prognosis with limited treatment options and less than 30% five-year survival rate.
Puma Biotechnology Reports Strong Financial Performance for Q4 and Full Year 2024
• Puma Biotechnology reported Q4 2024 net income of $19.3 million ($0.39 per share), a significant increase from $12.3 million in Q4 2023, driven by strong NERLYNX sales and a $7.1 million tax benefit.
• The company achieved full-year 2024 net income of $30.3 million ($0.62 per share), marking its third consecutive year of profitability while maintaining a strong cash position of approximately $101 million.
• Puma advanced its clinical pipeline with the initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer.
T-DM1 Shows Sustained Survival Benefit in HER2-Positive Breast Cancer
• Adjuvant trastuzumab emtansine (T-DM1) demonstrates significantly improved overall survival compared to trastuzumab in HER2-positive early breast cancer patients with residual invasive disease.
• The KATHERINE trial's long-term follow-up reveals a sustained benefit in invasive disease-free survival with T-DM1, reducing the risk of recurrence or death.
• T-DM1's consistent benefit across patient subgroups, regardless of disease extent or hormone receptor status, reinforces its role as a standard of care.
• While adverse events were more frequent with T-DM1, the overall safety profile remains acceptable, supporting its use in high-risk HER2-positive breast cancer.
Novel HER2-Targeted Therapies Show Promise in Overcoming Treatment Resistance in Advanced Breast Cancer
• New HER2-directed antibody-drug conjugate SHR-A1811 demonstrates impressive 76.3% response rate in HER2-positive breast cancer patients, with potentially improved safety profile compared to existing treatments.
• Bispecific antibody zanidatamab combined with evorpacept shows 55.6% response rate in heavily pretreated patients who progressed on T-DXd, offering hope for resistant disease.
• Research reveals potential resistance mechanisms to HER2-targeted therapies, including topoisomerase I alterations and HER2 gene loss, helping guide future treatment strategies.
Puma Biotechnology's Stock Surges Amid Promising Nerlynx Sales and Alisertib Development
• Puma Biotechnology's stock has increased by 24% over the past three months, driven by strong sales of Nerlynx and progress in alisertib development.
• Nerlynx sales for the first nine months of 2024 reached $140.8 million, leading to an updated full-year sales guidance of $187-$190 million.
• Puma Biotechnology initiated the Phase II ALISCA-Breast1 study to evaluate alisertib in metastatic breast cancer, with potential FDA approval pathway.
• A Phase II study, ALISCA-Lung1, is also underway to assess alisertib as a monotherapy for extensive stage small cell lung cancer, with interim data expected in 2025.
Puma Biotechnology Launches Phase II Trial of Alisertib for HR-Positive Metastatic Breast Cancer
• Puma Biotechnology has initiated ALISCA™-Breast1, a Phase II clinical trial evaluating alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer patients.
• The company is expanding its alisertib development program, which began with ALISCA™-Lung1 in February 2024 for extensive-stage small cell lung cancer as monotherapy.
• Alisertib, an oral aurora kinase A inhibitor acquired by Puma in 2022, represents the company's strategic expansion beyond its FDA-approved NERLYNX® (neratinib) franchise for HER2-positive breast cancer.
Drug Development Updates
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