NHS England Approves Two Life-Extending Breast Cancer Drugs After Initial Rejection
核心洞察
The NHS in England has approved Alpelisib (Piqray) and Trodelvy for approximately 3,500 women with advanced breast cancer (搜索) annually, following an initial rejection by NICE earlier in 2022.
Alpelisib, used with Fulvestrant, targets PIK3CA gene mutations and can stop cancer growth for six months in half of patients, while Trodelvy extends life by around five months for triple negative breast cancer (搜索) patients.
Both drugs represent significant advances in delaying chemotherapy and improving quality of life for women with incurable secondary breast cancer (搜索).
Thousands of breast cancer (搜索) patients in England will gain access to two life-extending treatments following a significant policy reversal by the National Institute for Health and Care Excellence (Nice). The health watchdog has approved Alpelisib and Trodelvy for NHS use after initially rejecting both drugs earlier in 2022, marking a crucial milestone for women with advanced breast cancer.
Alpelisib Targets Genetic Drivers of Cancer Growth
Alpelisib, manufactured by Novartis and also known as Piqray, will be used in combination with the hormone therapy Fulvestrant to target the gene responsible for fast-growing tumours. The drug works by blocking the gene's ability to help cancer cells survive and proliferate.
Clinical evidence demonstrates the treatment's effectiveness, with one study showing that half of people who received the combination therapy after previous treatments were able to stop cancer growth for six months. Patients eligible for treatment must have a mutation in the PIK3CA gene and have explored other treatment options first. An estimated 3,000 patients will benefit from this therapy annually.
Dr. Sacha Howell, Senior Clinical Lecturer, explained that the approval offers "a valuable new approach to treatment for patients with cancers that have the PIK3CA mutation." He noted that the genetic test for this mutation was recently approved and is freely available to all women with oestrogen receptor positive Her2 negative breast cancer (搜索).
"If the mutation is identified then Alpelisib, in combination with the anti-oestrogen Fulvestrant, offers approximately 6 months delay in cancer progression and the requirement for chemotherapy," Howell stated. He emphasized that while side effects require careful management, overall quality of life did not deteriorate significantly with this combination.
Trodelvy Advances Triple Negative Breast Cancer Treatment
Trodelvy, also called Sacituzumab Govitecan and manufactured by Gilead Sciences, has been approved to treat triple negative breast cancer (搜索) that cannot be removed surgically. This form of cancer is more common in women under 40 and affects approximately 15% to 20% of all women with breast cancer (搜索). About 650 patients will gain access to Trodelvy through this approval.
The drug operates as an antibody-drug conjugate, targeting a protein called TROP2 (搜索) on the surface of tumour cells, which is expressed on 90% of triple negative breast cancers. Clinical trials demonstrate that the drug can slow disease progression by several months and extend patients' lives by around five months compared with traditional chemotherapy.
Nice specified that the drug can be considered as a treatment option after women have already received "two or more systemic therapies." Dr. Howell described Trodelvy as "an exciting new drug" that delivers chemotherapy directly to cancer cells through its antibody component, resulting in "far fewer side effects than would be experienced if the same chemotherapy was delivered on its own."
The clinical data showed "impressive activity in inducing cancer shrinkage, prolonging cancer control and most importantly doubling the length of time patients stayed alive," according to Howell.
Significance for Patient Care
Both drugs will be made available through the NHS Cancer Drugs Fund, with Alpelisib representing the 100th treatment to be rapidly made available to NHS patients through this mechanism. John Stewart, national director for specialised commissioning for the NHS in England, emphasized that the treatments would help thousands of patients live with better quality of life.
Baroness Delyth Morgan, chief executive of Breast Cancer (搜索) Now, described the Trodelvy approval as "a momentous and hugely anticipated milestone for certain women living with incurable triple negative secondary breast cancer (搜索)." Following what she termed a "devastating provisional rejection in April," the decision will offer "a new, effective treatment for these women, and crucially give them the hope of invaluable extra months to live and do what matters most to them and their loved ones."
Helen Knight, interim director of medicines evaluation at Nice, noted that both drugs "are effective additional options that hold out the hope of a longer and a better quality of life for people with these types of advanced breast cancer (搜索)." She highlighted that both treatments represent "another step in delaying chemotherapy, allowing people to stay well for longer."
The approvals follow constructive negotiations between the pharmaceutical companies, Nice, and NHS England to establish agreements that make both treatments routinely available for approximately 3,450 people with advanced breast cancer (搜索) annually.