High cholesterol levels have been associated with breast cancer spreading to other sites in the body, but doctors and researchers don't know the cause for the link. A new study by University of Illinois researchers found that the culprit is a byproduct of cholesterol metabolism that acts on specific immune cells so that they facilitate the cancer's spread instead of stopping it.
Cynvenio Biosystems has initiated a clinical study to evaluate its LiquidBiopsy ClearID test in combination with NK Score natural killer cell activity to monitor breast cancer patients in the US.
Since the discovery of cyclin-dependent kinases (CDKs), scientists have been trying to target them to disrupt cancer cell division and proliferation. Breast cancer in particular relies on this process to grow. Because of this, the first-generation CDK inhibitors targeting CDK4 and CDK6 have been very successful. In February 2015, palbociclib, the first CDK4/6 inhibitor developed by Pfizer, was approved for marketing in the United States for the treatment of locally advanced or metastatic breast cancer of HR/HER2-. There are many breast cancer patients, and in 2020, there were more than 2.3 million new breast cancer patients in the world, making it the world’s largest cancer type. Based on the large patient size, the sales scale of palbociclib is also considerable. In 2016, the sales of palbociclib in the first full year of marketing reached 2.135 billion US dollars, becoming a well-deserved blockbuster drug. Since then, CDK4/6 inhibitors of Eli ...
Ductal carcinoma in situ (DCIS) is a non-invasive type of tumor that can sometimes progress to a more lethal form of breast cancer and represents about 25% of all breast cancer cases. Between 30% and 50% of DCIS patients may develop an invasive stage of cancer, yet identifying which tumors will progress is still a challenge due to unknown biomarkers. Current diagnostic practices include multiplexed staining or single-cell RNA sequencing to determine DCIS stages in tissue samples, but these methods are costly and not widely used. This has led to potential overtreatment of patients with DCIS. Now, a new artificial intelligence (AI) model can distinguish different stages of DCIS from inexpensive and readily available breast tissue images. The model developed by an interdisciplinary team of researchers from MIT (Cambridge, MA, USA) and ETH Zurich (Zurich, Switzerland) was trained and tested using one of the largest datasets of its kind ...
By Don Tracy, Associate Editor Reportedly, the liquid formulation of Tepylute eliminates the need for complex and time-consuming reconstitution, providing consistent dosing accuracy and allowing for timely preparation. The FDA has approved Shorla Oncology’s Tepylute, a ready-to-dilute formulation designed to treat breast and ovarian cancer. According to the company, the formulation is an easier to prepare injectable product that enables dosing accuracy, addressing the shortcomings and handling complexities associated with the current lyophilized powder formulation. Additionally, Shorla stated that the new formulation eliminates the need for complex and time-consuming reconstitution, enabling consistent dosing accuracy.1 ‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” said Sharon Cunningham, CEO, co-founder, Shorla Oncology, in a press release. “We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a ...
Breast cancer was responsible for 2.3 million diagnoses and 670,000 deaths globally in 2022 A new report led by the University of Cambridge and supported by the National Institute for Health and Care Research (NIHR) has highlighted inequalities among people living with breast cancer. Published by the Lancet Commission, the report sets out several recommendations to tackle these challenges in breast cancer and builds on previous evidence, new data and patient voices. According to the World Health Organization, breast cancer was responsible for 2.3 million diagnoses and 670,000 global deaths in 2022. Despite recent improvements in breast cancer, including advances in diagnosis and treatment, many people are still disproportionately affected. The commission revealed that progress in research and cancer management has led to a decrease of over 40% in breast cancer mortality, with estimates suggesting that the global breast cancer incidence will increase from 2.3 million new cases in 2020 ...
Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations. Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable. Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation. Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast ...
Pharmaceutical Executive Editorial Staff SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024. “This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release. The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the ...
Roche has shared positive results from a late-stage study of its investigational therapy, inavolisib, as part of a combination treatment for advanced breast cancer. The phase 3 INAVO120 trial has been evaluating the targeted drug alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant as a potential first-line treatment option for patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to palbociclib and fulvestrant alone. A “clear positive trend” towards improved survival was also observed for the inavolisib combination, Roche said, although overall survival data was immature at the time of the analysis and will continue to be analysed. Breast cancer is the most common cancer worldwide, with more than 290,000 people in the US expected to be diagnosed with the disease in 2023. HR-positive breast cancer is ...
AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients. The FDA’s decision specifically applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with at least one of three biomarker alterations: PIK3CA, AKT1 or PTEN. The US regulator has also approved the use of a companion diagnostic test to detect the relevant alterations. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023. HR-positive breast cancer is the most common subtype, with over 65% of tumours considered HR-positive and HER2-low ...
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