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Details:
R115777 (tipifarnib), a potent, selective and orally bioavailable FTI, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration-directed trial (AIM-HN) in patients with this devastating disease.
Lead Product(s): Tipifarnib,Alpelisib
Therapeutic Area: Oncology Product Name: R115777
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Result of retrospective biomarker analysis finding that different genetic mutation profiles in tumors harboring PIK3CA mutation did not affect treatment benefit with Piqray (alpelisib) plus fulvestrant in patients with HEGFR-2 negative advanced or metastatic breast cancer.
Lead Product(s): Alpelisib
Therapeutic Area: Oncology Product Name: Piqray
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
Approval based on real-world data from EPIK-P1 study, which showed patients treated with Vijoice (alpelisib) experienced reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.
Lead Product(s): Alpelisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Vijoice
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Zarnesta (tipifarnib), a potent, selective and orally bioavailable farnesyl transferase inhibitor, is currently in a registration-directed trial (AIM-HN) in patients with this devastating disease.
Lead Product(s): Tipifarnib,Alpelisib
Therapeutic Area: Oncology Product Name: Zarnesta
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
Combination of tipifarnib, a farnesyl transferase inhibitor with Novartis’ alpelisib, a PI3Kα inhibitor provide greater antitumor activity, relative to inhibiting either target alone. The combination has potential to address up to 50% of patients with HNSCC in KURRENT trial.
Lead Product(s): Tipifarnib,Alpelisib
Therapeutic Area: Oncology Product Name: Zarnesta
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2021
Details:
New data underscore efficacy of Piqray (alpelisib), even in those patients with a short treatment duration on prior CDK4/6i or with ESR1 mutations, biomarkers of endocrine resistance.
Lead Product(s): Alpelisib,Fulvestrant
Therapeutic Area: Oncology Product Name: Piqray
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Details:
Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumours harbor a PIK3CA mutation, which stimulates tumour growth and is associated with poor response to therapy.
Lead Product(s): Alpelisib,Fulvestrant
Therapeutic Area: Oncology Product Name: Piqray
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 29, 2020
Details:
Investigators at Nagourney Cancer Institute will report at the AACR Virtual Annual Meeting, June 22-24, that Alpelisib (BYL 719) may have an important role in the treatment of advanced uterine cancer as well as a number of other tumor types.
Lead Product(s): Alpelisib
Therapeutic Area: Oncology Product Name: BYL 719
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2020