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Details:
Nerlynx (neratinib) is a kinase inhibitor that irreversibly binds to EGFR, HER2, and HER4. It reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
As a small molecule that can cross the blood brain barrier, Nerlynx (neratinib) potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option.
Lead Product(s): Neratinib,Capecitabine,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
Lead Product(s): Neratinib,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2022
Details:
The results suggest that the combination of Nerlynx (neratinib), fulvestrant, and trastuzumab together is promising for treating HR+ and HER2-mutated MBC with prior exposure to CDK4/6i across a range of HER2 mutations.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
Efficacy results from the BTC cohort of 25 patients for Nerlynx (Neratinib) demonstrated an overall response rate (ORR) of 16%, 95% CI 4.5-36.1%), median progression free survival (PFS) of 2.8 months and overall survival (OS) of 5.4 months.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2022
Details:
NERLYNX (Neratinib) is prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated with trastuzumab-based therapy.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
Nerlynx (neratinib) is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors, or EGFRs, HER1, HER2 and HER4.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
NERLYNX approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2021
Details:
The second tranche of $25 million may be drawn at a later date; if drawn down these proceeds would be used for general corporate purposes and to further support NERLYNX® commercial initiatives.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Athyrium Capital Management
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Funding July 26, 2021
Details:
Patients in the dose escalation cohort received NERLYNX 120 mg daily for Week 1, followed by NERLYNX 160 mg daily for Week 2, followed by NERLYNX 240 mg daily for Week 3 and thereafter for the duration of treatment.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
The amended agreement extends Pierre Fabre’s commercial rights for NERLYNX to Greater China, which includes mainland China, Taiwan, Hong Kong and Macau.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pierre Fabre
Deal Size: $70.0 million Upfront Cash: $50.0 million
Deal Type: Expanded Collaboration February 25, 2021
Details:
The parties have agreed to terminate their 2018 license agreement, in which Puma granted CANbridge exclusive rights to develop and commercialize NERLYNX® (neratinib) in Greater China, and to settle their arbitration related to the license agreement.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CANbridge Pharmaceuticals
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Termination February 25, 2021
Details:
The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2021
Details:
The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that included a cohort evaluating the safety and efficacy of neratinib administered daily to patients who have HER2 (ERBB2) mutation-positive advanced biliary cancer.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
The presentation entitled, “Impact of neratinib plus capecitabine on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial,” is being presented at a Spotlight Poster Discussion Session.
Lead Product(s): Neratinib,Capecitabine
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
The descriptive analyses in HR+ patients who received neratinib within one year of completing trastuzumab and did not achieve a pCR post neoadjuvant therapy suggest that neratinib may be associated with improved OS in this high-risk group.
Lead Product(s): Neratinib,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 (ERBB2) or lung cancers with EGFR exon 18 mutations.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
Latest findings from the breast cancer cohort in SUMMIT - a phase 2 'basket' trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer will be presented at the San Antonio Breast Cancer Symposium.
Lead Product(s): Neratinib,Trastuzumab,Fulvestrant
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
The National Comprehensive Cancer Network plans to evaluate neratinib, type of tyrosine kinase inhibitor that works as a dual inhibitor of the epidermal growth factor receptor 1 and HER2. The research funding is supported by Puma Biotechnology.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Puma Biotechnology
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration October 15, 2020
Details:
The SNDS is supported by the results of the Phase IIINALA trial, a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in HER2-positive metastatic breast cancer patients previously treated with = 2 HER2-directed regimens.
Lead Product(s): Neratinib,Capecitabine
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
The international, open-label, sequential-cohort Phase II CONTROL trial is investigating several strategies to improve neratinib tolerability.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
Details:
CANbridge has received marketing approval from the Taiwan Food and Drug Administration for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2020
Details:
Phase II SUMMIT ‘basket’ trial is an open-label, international multi-histology study to evaluate the safety and efficacy of neratinib, administered daily to patients, across a broad spectrum of cancer types in patients whose tumors harbor activating HER2 somatic mutations.
Lead Product(s): Neratinib,Loperamide Hydrochloride
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
Acentrus Specialty has finalized an agreement with Puma Biotechnology to provide qualified Acentrus clients access to NERLYNX® (neratinib).
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acentrus Specialty
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 21, 2020
Details:
NERLYNX significantly reduce the ongoing risk of recurrence in HER2+ early breast cancer patients with the greatest benefit seen in women who are also HR+and who commence therapy within 12 months of completing trastuzumab-based therapy.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2020
Details:
Bixink will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing NERLYNX in South Korea.
Lead Product(s): Neratinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bixink Therapeutics
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 30, 2020
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