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

SIRIO Pharma opens multimillion gummy production plant

SIRIO Pharma opens multimillion gummy production plant

18 Oct 2018

The new ‘Centre of Excellence’ already boasts one of the world’s most advanced gummy production line designed to meet demand from global markets.

Read more 
New formulation modelling successes using ex vivo tissue

New formulation modelling successes using ex vivo tissue

9 Oct 2018

One study uses the company's proprietary TurChub model, to evaluate the diffusion and subsequent activity of drugs in human nails.

Read more 
Three-way collaboration to advance gene therapy

Three-way collaboration to advance gene therapy

4 Oct 2018

Partnership aims to increase the robustness and reduce costs for the manufacturing of AAV vectors.

Read more 
New oral treatment for metastatic melanoma receives EU authorisation

New oral treatment for metastatic melanoma receives EU authorisation

24 Sep 2018

Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).

Read more 
Plasticell wins military contract to develop regenerative medicines for the battlefield

Plasticell wins military contract to develop regenerative medicines for the battlefield

4 Sep 2018

Company to use its combinatorial stem cell screening platform to develop technologies for the conversion of pluripotent stem cells into platelets.

Read more 
New biopharmaceutical testing laboratory to open in Geneva

New biopharmaceutical testing laboratory to open in Geneva

28 Aug 2018

SGS's expansion will enable the service provider to offer a full ICH Q6B physico-chemical characterization of biological products.

Read more 
Exosome isolation manufacturing and characterization

Exosome isolation manufacturing and characterization

13 Aug 2018

New service to reliably and reproducibly isolate exosomes from almost any biofluid.

Read more 
Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines

Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines

8 Aug 2018

Company moves away from manual processing in favour of automated, scalable platforms.

Read more 
A new era for migraine patients

A new era for migraine patients

6 Aug 2018

EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.

Read more 
WuXi STA and Antengene sign development and manufacturing agreement

WuXi STA and Antengene sign development and manufacturing agreement

24 Jul 2018

WuXi STA chosen for its end-to-end CMC platform for new drug development.

Read more