All articles tagged with #kisqali
The FDA issued an untitled letter to Novartis, criticizing a TV commercial for the breast cancer drug Kisqali as containing "false or misleading" information. The ad, which featured a "Long Live" tagline and ran from 2022 to September 2023, was flagged for potentially giving metastatic breast cancer patients an exaggerated impression of the drug's effectiveness in treating their condition and symptoms.
Novartis' breast cancer drug Kisqali has reduced the risk of recurrence by over 25% in a pivotal trial on women diagnosed at an early stage. The drug was used in the trial together with standard endocrine therapy to treat a type of cancer that grows in response to hormones and it was compared to endocrine therapy alone. The drug has been approved to treat hormone-driven breast cancer that has spread to other parts of the body, where Novartis has taken market share from Pfizer's Ibrance. Novartis will request approval for wider use in the US and Europe before the end of the year.
Novartis has announced that its breast cancer treatment Kisqali, already approved by the FDA for advanced stages of breast cancer, can reduce the risk of cancer coming back when added after primary treatment. The drug could be good news for women diagnosed in the earlier stages of the disease and those who are hormone-receptor positive and HER2 negative, who make up 70% of the breast cancer population. The findings were announced at the annual meeting of the American Society of Clinical Oncology, and Novartis plans to submit the data to regulatory authorities in the US and Europe before the end of the year.
Novartis reported a beat-and-raise Q1 report, with sales of heart failure drug Entresto surging 32%, Kisqali sales rocketing 81%, and Kesimpta revenue doubling. The company's innovative medicines and generics business also beat expectations. However, sales of immunology drug Cosentyx came in light, and Novartis may struggle to find acquisition targets against more financially secure rivals. Novartis confirmed its plan to spin off the Sandoz division in the second half of the year and raised its outlook for the year, expecting sales to grow by a mid-single-digit percentage.
Novartis shares rose after the Swiss pharma company reported positive trial data for its breast-cancer treatment Kisqali, which exhibited positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali, in a broad population of patients with early breast cancer. The Independent Data Monitoring Committee recommended stopping the trial early because the primary endpoint of invasive disease-free survival had been met. Analysts from Jefferies said the report could represent a $6 billion opportunity as it implies at least a 2% to 4% upside on earnings per share and 2% to 3% on net present value.
Novartis's Kisqali breast cancer drug has shown a clear benefit in cutting the risk of recurrence in women diagnosed with early-stage breast cancer, according to a pivotal trial. The trial was stopped early after an interim analysis showed a clear benefit. Kisqali has been approved to treat hormone-driven breast cancer that has spread to other body parts, but the earlier-stage setting is seen as a much larger market. Kisqali is one of two new drugs with a particularly important role for the group's future sales growth.