This section highlights FDA-related milestones and regulatory updates for drugs developed by Puma Biotechnology (PBYI).
Over the past two years, Puma Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
alisertib, NERLYNX, and trastuzumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Alisertib FDA Regulatory Events
Alisertib is a drug developed by Puma Biotechnology for the following indication: For the Treatment of Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- alisertib
- Announced Date:
- September 17, 2026
- Indication:
- For the Treatment of Small Cell Lung Cancer
Announcement
Puma Biotechnology, Inc announced the initiation of its ALISertib in CAncer (ALISCA®-Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757) of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer.
Read Announcement- Drug:
- alisertib
- Announced Date:
- November 20, 2024
- Indication:
- For the Treatment of Small Cell Lung Cancer
Announcement
Puma Biotechnology, Inc. announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer who have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.
AI Summary
Puma Biotechnology, Inc. has launched a Phase II trial called ALISCA™-Breast1 to study alisertib in combination with endocrine therapy for patients with hormone receptor-positive (HR+), HER2-negative recurrent or metastatic breast cancer. This trial will include up to 150 patients who have previously been treated with CDK4/6 inhibitors and at least two lines of endocrine therapy. Patients will be randomly assigned to receive alisertib at doses of 30 mg, 40 mg, or 50 mg twice daily on specific days of a 28-day cycle, alongside the endocrine therapy chosen by their doctor.
The primary aim of the study is to determine the optimal dose of alisertib when used in this combination. Key measurements will include response rate, duration of response, disease control rate, progression-free survival, and overall survival. Biomarker analyses will also be conducted to identify any subgroups that might benefit most from the treatment, with initial trial data expected in 2025.
Read Announcement
NERLYNX (neratinib) FDA Regulatory Events
NERLYNX (neratinib) is a drug developed by Puma Biotechnology for the following indication: HER2-Positive Early Stage and Metastatic Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NERLYNX (neratinib)
- Announced Date:
- April 30, 2025
- Indication:
- HER2-Positive Early Stage and Metastatic Breast Cancer
Announcement
Er-Kim announced that it has signed an agreement with Puma Biotechnology, Inc to commercialize NERLYNX® (neratinib) in select countries in Eastern Europe and Central Asia. NERLYNX is designed to block human epidermal growth factor receptor 2 (HER2) in order to treat and limit breast cancer metastasis.
AI Summary
Er-Kim has signed an agreement with Puma Biotechnology, Inc. to commercialize NERLYNX® (neratinib) in select countries in Eastern Europe and Central Asia. This decision means that Er-Kim will act as the distribution partner for NERLYNX in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan.
NERLYNX is a prescription medicine designed to block the human epidermal growth factor receptor 2 (HER2), helping to treat and limit the spread of breast cancer. It is used for adult patients who have early-stage HER2-positive breast cancer that has been treated with trastuzumab-based therapy and for those with metastatic breast cancer when used with capecitabine after other anti-HER2 treatments.
Read Announcement- Drug:
- NERLYNX (neratinib)
- Announced Date:
- December 23, 2024
- Indication:
- HER2-Positive Early Stage and Metastatic Breast Cancer
Announcement
Puma Biotechnology, Inc. announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer were updated to include an addition involving neratinib (NERLYNX®).
AI Summary
Puma Biotechnology recently announced that the National Comprehensive Cancer Network (NCCN) Guidelines for Cervical Cancer have been updated to include neratinib (NERLYNX®) as a treatment option. Through its inclusion as a Category 2A recommendation, neratinib monotherapy can now be used as a second-line or later treatment for patients with recurrent or metastatic cervical cancer who have HER2-mutated tumors. This update is supported by data from the Phase II SUMMIT trial, which showed positive results in patients with histologically confirmed advanced cervical cancer and an activating HER2 mutation. Puma Biotechnology’s CEO, Alan H. Auerbach, emphasized that incorporating neratinib into the NCCN Guidelines will help raise awareness and assist healthcare providers in making informed treatment decisions to address this significant unmet need.
Read Announcement
Trastuzumab FDA Regulatory Events
Trastuzumab is a drug developed by Puma Biotechnology for the following indication: in combination with neratinib in solid tumors with HER2 alterations.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- trastuzumab
- Announced Date:
- April 28, 2025
- Indication:
- in combination with neratinib in solid tumors with HER2 alterations
Announcement
Puma Biotechnology, Inc. announced that clinical data on neratinib were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025.
AI Summary
Puma Biotechnology, Inc. shared promising clinical findings on neratinib at the AACR Annual Meeting 2025 in Chicago. During a poster session, Andrew A. Davis from Washington University School of Medicine presented data from a Phase I trial titled “CT071: Phase I trial of trastuzumab deruxtecan in combination with neratinib in solid tumors with HER2 alterations (NCI 10495).” The study evaluated the safety and tolerability of the combination of trastuzumab deruxtecan and neratinib, targeting patients with solid tumors that have HER2 alterations. Early results showed that the combination had a manageable safety profile along with early indications of anti-tumor activity. The findings suggest that the treatment could be effective, especially for hard-to-treat cancers. Puma Biotechnology is encouraged by these results and looks forward to further evaluation in the upcoming Phase II studies.
Read Announcement
