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Details:
Kisqali-Generic (ribociclib) is a cyclin-dependent kinase 4/6 inhibitor, which is indicated for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Lead Product(s): Ribociclib
Therapeutic Area: Oncology Product Name: Kisqali-Generic
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 02, 2024
Details:
Under the collaboration, Novartis will increase the size of the ongoing Phase 1/2 study testing OP-1250 (palazestrant), an orally-available small molecule with dual activity as both a complete ER antagonist and a selective ER degrader, in combination with ribociclib.
Lead Product(s): Palazestrant,Ribociclib
Therapeutic Area: Oncology Product Name: OP-1250
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Expanded Collaboration October 10, 2023
Details:
Kisqali® (ribociclib) is the only USFDA approved category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.
Lead Product(s): Ribociclib,Anastrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2023
Details:
Kisqali (ribociclib) is the only CDK4/6 inhibitor with proven overall survival benefit across all three pivotal Phase III advanced breast cancer trials and is recognized as the only CDK4/6i with overall survival benefit in first-line HR+/HER2- advanced breast cancer.
Lead Product(s): Ribociclib,Anastrozole,Goserelin Acetate
Therapeutic Area: Oncology Product Name: Kisqali
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 06, 2022
Details:
Kisqali (ribociclib) is a unique CDK4/6 inhibitor, consistently demonstrating statistically significant OS benefit while maintaining or improving quality of life across three Phase III trials, regardless of patient or disease characteristics.
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Translational Research In Oncology
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2022
Details:
Overall survival results from pooled exploratory analysis of MONALEESA trials in patients with aggressive HR+/HER2- advanced breast cancer treated with Kisqali® (ribociclib).
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
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 30, 2022
Details:
In new exploratory analysis of data from MONALEESA-2 study, Kisqali (ribociclib) plus letrozole maintained an OS benefit for postmenopausal patients with metastatic breast cancer treated in first-line, including for those patients who required dose modification of Kisqali.
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
Latest in HR+/HER2- metastatic breast cancer, including data on CDK recycling with Kisqali® plus endocrine therapy, further MONALEESA-2 quality of life and overall survival analyses, and a new biomarker analysis of Piqray® plus fulvestrant.
Lead Product(s): Ribociclib,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
With further follow-up of MONALEESA-3, Kisqali (ribociclib) plus fulvestrant achieved a median overall survival (OS) of more than five-and-a-half years (67.6 months) in the first-line (1L) setting for postmenopausal women living with HR+/HER2- aBC.
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2022
Details:
MONALEESA-2 results show a statistically significant more than one-year increase in survival for women with HR+/HER2- postmenopausal aBC when using Kisqali plus letrozole compared to letrozole alone as first-line therapy.
Lead Product(s): Ribociclib,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
Kisqali (ribociclib), data demonstrating a consistent OS benefit with Kisqali plus endocrine therapy (ET) across genomic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (mBC).
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2021
Details:
The primary endpoint of HARMONIA is progression free survival (PFS), and the study will evaluate if Kisqali positively alters tumor biology, enabling a better response to endocrine therapy compared to Ibrance®.
Lead Product(s): Ribociclib
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SOLTI Innovative Cancer Research
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 19, 2021
Details:
MONALEESA-2 final analysis showed Kisqali, a CDK4/6 inhibitor in combination with letrozole has reported statistically significant overall survival benefit with aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in first-line (1L) setting.
Lead Product(s): Ribociclib,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2021
Details:
Overall survival results from the phase III MONALEESA-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative advanced breast cancer treated with endocrine therapy (ET) ± ribociclib Kisqali (ribociclib).
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2021
Details:
Ribociclib belongs to a class of targeted therapies called CDK4/6 inhibitors. Cyclin-dependent kinases 4 and 6 are proteins that help regulate cell replication and proper cell cycle function.
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
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 21, 2021
Details:
KISQALI is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival with various endocrine treatment partners and the broadest spectrum of patients in two Phase III trials in advanced breast cancer.
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2021
Details:
Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up.
Lead Product(s): Ribociclib,Tamoxifen Citrate,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
KISQALI® is the first CDK4/6 inhibitor to show statistically significant improvement in overall survival (key secondary endpoint) in advanced breast cancer in pre- and perimenopausal women.
Lead Product(s): Ribociclib,Tamoxifen Citrate,Goserelin Acetate
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Novartis will evaluate OP-1250 and a selective ER degrader (SERD), in combination with each of Kisqali® (ribociclib) and Piqray® (alpelisib) in patients with recurrent, locally advanced or metastatic estrogen receptor-positive (ER+), HER2 (-) breast cancer.
Lead Product(s): OP-1250,Ribociclib
Therapeutic Area: Oncology Product Name: OP-1250
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 26, 2020
Details:
Kisqali is the only CDK4/6 inhibitor, in combination with endocrine therapy, to achieve a perfect 5 out of 5 score, confirming substantial benefit for premenopausal women with HR+/HER2- advanced breast cancer, based on strong overall survival benefit in the MONALEESA-7 trial.
Lead Product(s): Ribociclib,Tamoxifen Citrate,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The collaboration is focused on a investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali®), a CDK4/6 inhibitor, for the treatment of ER-positive breast cancer (LEADER).
Lead Product(s): Ribociclib,Hormone therapy
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Massachusetts General Hospital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 27, 2020
Details:
Subgroup analysis shows Kisqali plus endocrine therapy extended life compared to endocrine therapy for patients with liver metastases – showing ~47% and 37% reduction in the risk of death in M7 and M3, respectively.
Lead Product(s): Ribociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
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