Novartis Kisqali receives FDA Breakthrough Therapy designation

3 Jan 2018

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal women who received no prior endocrine therapy for advanced disease.

Novartis has announced Kisqali (ribociclib) received FDA Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.

Novartis Kisqali receives FDA Breakthrough Therapy designation

This Breakthrough Therapy designation is based on positive results of the Phase III MONALEESA-7 trial demonstrating Kisqali in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone. A total of 672 women ranging from 25 to 58 years in age were enrolled and randomized in the trial. All treatment combinations also included goserelin. Treatment benefit with Kisqali combination therapy was consistent compared to the overall population regardless of treatment with tamoxifen or aromatase inhibitor endocrine partners, and across predefined patient subgroups.

"This Breakthrough Therapy designation reflects the significance and promise of the MONALEESA-7 data presented at SABCS last month," said Samit Hirawat, Head, Novartis Oncology Global Drug Development. "Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease. We look forward to working with FDA to make this combination therapy available to premenopausal women living with HR+/HER2- advanced breast cancer in the US as soon as possible."

MONALEESA-7 was the first Phase III trial entirely dedicated to evaluating a CDK4/6 inhibitor in premenopausal women with HR+/HER2- advanced breast cancer. The trial evaluated Kisqali in combination with oral endocrine therapies (tamoxifen or an aromatase inhibitor) and goserelin compared to oral endocrine therapy and goserelin in this patient population. In subgroup analyses of median PFS by endocrine partner, Kisqali in combination with tamoxifen and goserelin demonstrated 22.1 months median PFS compared to 11.0 months for tamoxifen and goserelin alone; Kisqali in combination with an aromatase inhibitor and goserelin demonstrated 27.5 months median PFS compared to 13.8 months for an aromatase inhibitor and goserelin alone.

No new safety signals were observed in the MONALEESA-7 trial; adverse events were generally consistent with those observed in MONALEESA-2, identified early and mostly managed through dose interruptions or reductions. Combination treatment with Kisqali was well tolerated with a discontinuation rate due to adverse events of 3.6% compared to 3.0% in patients who received endocrine therapy alone. The most common (>=5%) grade 3/4 adverse events in patients receiving Kisqali combination therapy compared to endocrine therapy alone were neutropenia (60.6% vs 3.6%) and leukopenia (14.3% vs 1.2%).

Premenopausal breast cancer is a biologically distinct and more aggressive disease than postmenopausal breast cancer, and it is the leading cause of cancer death in women 20-59 years old.

This Breakthrough Therapy designation marks the second for Kisqali. The first Breakthrough Therapy designation for Kisqali was granted in August 2016 based on results of the Phase III MONALEESA-2 trial.

Read More

Related news

Natural lipid acts as potent anti-inflammatory

Natural lipid acts as potent anti-inflammatory

10 Jul 2018

Scientists see therapeutic potential against bacteria, viruses.

Read more 
Plasticell leads gene therapy manufacturing consortium

Plasticell leads gene therapy manufacturing consortium

3 Jul 2018

Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies.

Read more 
Follicum develops new direct-to-scalp formulation

Follicum develops new direct-to-scalp formulation

27 Jun 2018

The topical treatment for hair loss boasts a 'commercial' formulation.

Read more 
Collaboration to provide GMP-based services

Collaboration to provide GMP-based services

19 Jun 2018

Researchers to benefit by receiving a rapid and cost-effective scaled supply of new compounds.

Read more 
Locate Therapeutics secures £2 million to fast-track development of innovative cell therapy programs

Locate Therapeutics secures £2 million to fast-track development of innovative cell therapy programs

5 Jun 2018

TAOS matrix system and products hailed as potential ‘game changers’ in the field of regenerative medicine.

Read more 
Anti-vedolizumab antibodies to support treatment research

Anti-vedolizumab antibodies to support treatment research

25 May 2018

A reliable source of antibodies for the development of bioanalytical assays for vedolizumab, to support research into the treatment of ulcerative colitis and Crohn’s disease

Read more 
The shortest way from the lab to continuous production

The shortest way from the lab to continuous production

24 May 2018

Bosch's new Xelum R&D for continuous production of oral solid dosage forms ensures a short time-to-market and optimum dosing of APIs.

Read more 
Comparative analysis of a complex monoclonal antibody

Comparative analysis of a complex monoclonal antibody

24 May 2018

New poster describes how the EAF4 module enabled simultaneous measurement of size and surface charge characteristics of antibodies and proteins.

Read more 
Lilly expands oncology pipeline with acquisition

Lilly expands oncology pipeline with acquisition

16 May 2018

Acquisition of AurKa Pharma expands Lilly's oncology pipeline with early-phase asset being studied in multiple tumour types.

Read more 
Versatile lyophilizer for research, development or small-scale production

Versatile lyophilizer for research, development or small-scale production

15 May 2018

Allows for easy and intuitive scale-up from research.

Read more