Gilead Sciences Korea Ltd.

Gilead Science’s Trodelvy (sacituzumab govitecan-hziy) has been approved by the US Food and Administration (FDA) to treat metastatic breast cancer, the company announced. The authorisation is specifically for adult patients with unresectable locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. HR+/HER2- breast cancer is the most common type of breast cancer, accounting for around 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. Gilead’s US application was supported by results from its phase 3 TROPiCS-02 study, in which Trodelvy demonstrated significant progression-free survival and overall survival (OS) benefits in this patient group. In the study, Trodelvy showed a 34% reduction in risk of disease progression or death, as well as an OS benefit of 3.2 months over single-agent chemotherapy. Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration. “The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumour is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director at SurvivingBreastCancer.org. Trodelvy is already approved in more than 40 countries to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease. “We are pleased that Trodelvy could now provide new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer,” said Daniel O'Day, chairman and chief executive officer at Gilead. Trodelvy is also approved in the US under the accelerated approval pathway for pretreated adult patients with locally advanced or metastatic urothelial cancer.

Gilead Science and Kite, a Gilead company, have announced that the National Institute for Health and Care Excellence (NICE) has recommended Yescarta (axicabtagene ciloleucel) to treat certain forms of lymphoma. Specifically, the therapy is now recommended for adult patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) who have already been treated with two or more systemic therapies. The decision from NICE makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy to be recommended for routine use on the NHS. The therapy modifies patients’ own immune cells to allow them to attach to and kill cancer cells, The treatment was previously made available through the Cancer Drugs Fund (CDF) in 2018, but will now be commissioned routinely for patients in England after the NHS Commercial Medicines Directorate agreed on a confidential commercial deal with the company, NICE said. In its decision,  the organisation considered new evidence, including data from a clinical trial and from patients receiving the treatment through the CDF. Overall survival rates in the CDF, with data collected over 36 months, show the median overall survival of patients receiving Yescarta was 28.5 months, with 45% of patients alive after three years. Helen Knight, director of medicines evaluation at NICE, said: “I am delighted that we have been able to recommend this pioneering treatment for people. The evidence from its use in the CDF and clinical trials shows it can offer an effective treatment, helping people live longer and with a better quality of life.” DLBCL and PMBCL are both aggressive forms of non-Hodgkin lymphoma. After initial chemotherapy, up to 45% of patients with DLBCL will require a second-line treatment, which often involves high dose chemotherapy and a stem cell transplant. Of those who receive a transplant, about 50% will relapse. While there is currently no standard treatment for DLBCL or PMBCL after two or more systemic therapies, this decision from NICE will ensure that patients needing third-line treatment will continue to have access to CAR T-cell therapy. Dr Véronique Walsh, vice president and general manager, Gilead Sciences UK & Ireland said: “This news comes at a time when new hospitals are preparing to deliver CAR T-cell therapies, and will mean that healthcare professionals in these centres will have this treatment as an important option for their patients.”