Kisqali (ribociclib)

Omission of SLNB in patients with small HR-positive/HER2-negative tumors results in a missed indication for CDK4/6i in <8 % with minimal impact on recurrence.

The advent of CDK4/6 inhibitors, namely, palbociclib, ribociclib and abemaciclib, has changed the management of oestrogen receptor (ER)-positive/HER2-negative advanced breast tumours. Nonetheless, the acquired resistance to CDK4/6 inhibitors remains a major therapeutic challenge. Thus, the identification of molecular drivers involved in the resistance to these drugs is crucial for the design of novel therapeutic approaches and the selection of patient-centred strategies in various types of tumours.

Ribociclib plus letrozole met the primary end point, achieving meaningful response rates and durable disease control in recurrent LGSOC. The safety profile was consistent with prior CDK4/6 inhibitor studies. This combination represents a therapeutic option in this rare and genomically distinct subtype.

She was initiated on palbociclib and letrozole treatment in April 2024...She was commenced on ribociclib and letrozole for relapsed metastatic liver disease in April 2023...Understanding the role of CDK4/6 inhibition and the link with psoriasis is important for optimizing therapeutic choices for patients with cancer with pre-existing or newly developed psoriasis. Given the increasing use of CDK4/6 inhibitors in cancer treatment, clinicians should be vigilant of the potential increased prevalence of psoriasis experienced in this patient cohort.

Real-world data reveal drug- and age-specific toxicity differences. Ribociclib and abemaciclib pose higher risks in older adults compared to palbociclib, supporting the need for personalized treatment and careful monitoring in older patients.

Ribociclib (Ribo) and Abemaciclib (Abe) are new-generation CDK inhibitors approved for use in breast cancer treatment. Some molecular mechanisms were elucidated by revealing the synergistic effect of FA combined with Ribo and/or Abe in both HR positive and HR negative breast cancer and its possible toxicity or protection on normal breast cells. The present findings suggest that FA is a viable candidate for adjuvant or neoadjuvant treatment in combination with Ribo and/or Abe, as an alternative to Letrozole or Fulvestrant, which have been associated with significant adverse effects in clinical settings.

Patients with metastatic HR+HER2- IBC demonstrated a shorter time on treatment suggesting shorter duration of response on CDKI + HT, which is markedly inferior to reported data for non-IBC patients from phase III trials.

P2, N=200, Completed, Melanoma Institute Australia | Active, not recruiting --> Completed | N=1000 --> 200 | Trial completion date: Dec 2028 --> Dec 2025

P=N/A, N=2424, Completed, Novartis Pharmaceuticals | Recruiting --> Completed

At a WTP threshold of $150,000 per evLY, ribociclib demonstrated an approximately 100% probability of being cost-effective relative to palbociclib. Ribociclib improved health outcomes with a minimal relative cost increase and is therefore a highly cost-effective 1 L treatment option vs. palbociclib in patients with HR+/HER2- aBC from the Medicare perspective.

P=N/A, N=376, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P=N/A, N=2766, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2032 --> Dec 2032 | Initiation date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2032 --> Dec 2032