The US Food and Drug Administration (FDA) has granted fast track status to a new drug combination for BRCA-mutated advanced breast cancer.

The designation covers ART6043, developed by Artios, used with the PARP inhibitor Lynparza, also known as olaparib.

It applies to adults with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer who have not previously been treated with a PARP inhibitor.

BRCA mutations are inherited genetic changes that increase the risk of breast cancer.

PARP inhibitors block cancer cells from repairing damaged DNA, but tumours with BRCA mutations often develop resistance when these drugs are used alone.

ART6043 is designed to address this resistance. The oral treatment inhibits DNA polymerase theta, or Polθ, an enzyme found in cancer cells but largely absent in healthy tissue.

By blocking Polθ, the drug targets a backup DNA repair process known as microhomology-mediated end joining, which cancer cells rely on when other repair pathways are disrupted.

The aim is to limit the tumour’s ability to repair itself and extend the effectiveness of PARP inhibitors.

The fast track decision was supported by data from an ongoing first-in-human phase 1/2a trial evaluating ART6043 in combination with Lynparza in patients with advanced solid tumours carrying mutations in DNA damage response pathways, including BRCA-mutated breast cancer.

Findings presented at the European Society for Medical Oncology Congress 2025 showed what the company described as expected pharmacokinetic and pharmacodynamic activity, as well as encouraging clinical signals.

Breast cancer is the second leading cause of cancer death among women in the US. Patients with BRCA mutations who develop resistance to PARP inhibitors often have limited treatment options.

The FDA fast track programme is intended to speed up the development and review of investigational medicines that may address serious or life-threatening conditions with unmet medical need.

The designation allows Artios to engage more frequently and earlier with the FDA to discuss the development pathway for ART6043.

Under the programme, the drug candidate may be eligible for priority review and accelerated approval if it meets the relevant clinical criteria.

HER2-negative breast cancer does not overproduce the HER2 protein, which drives tumour growth in some patients.

Locally advanced cancer has spread to nearby tissue but not distant parts of the body, while metastatic cancer has spread to other organs.

Men and women with early Lyme disease show different symptoms, test results and clinical signs, according to a new study.

The research analysed data from 243 adults aged 20 to 84, including 118 women and 125 men, diagnosed with early Lyme disease before and after treatment.

Researchers found men were more likely to have a positive laboratory test and to show more obvious, severe indicators of disease at diagnosis, including other laboratory abnormalities.

However, there was no difference between men and women in how long they had been ill.

The study also identified symptoms reported more often by women, including heart palpitations, reported by 11.9 per cent of women compared with 4 per cent of men, vomiting, 7.6 per cent versus less than 1 per cent, and light sensitivity, 17 per cent versus 8.8 per cent.

Sleep difficulty was the only symptom reported more frequently by men, affecting 40 per cent compared with 24.6 per cent of women.

Men were found to have a disease pattern more similar to post-menopausal women than to pre-menopausal women, suggesting sex hormones may influence how early Lyme disease presents.

John Aucott, director of the Johns Hopkins Lyme Disease Clinical Research Center, said: “Males and females are different.

“For both findings, the male group was more similar to females who had undergone menopause and more different from females who had not.”

Further research is needed to determine the cause of these differences and their impact on time to diagnosis and the risk of developing later conditions after treatment.

Aucott said the next step will be to identify the mechanisms, such as hormone levels, underlying these differences.

An electronic nose using machine learning can detect early signs of ovarian cancer in blood samples with 97 per cent accuracy, according to researchers.

The device uses 32 sensors that react to volatile substances released from blood plasma.

Different cancers emit different substances, meaning each effectively has a distinct chemical pattern.

Rather than searching for a single biomarker, the system analyses a wide range of signals using machine-learning models trained to identify ovarian cancer.

The models are trained on known samples from a biobank, a collection of biological specimens used for research.

The approach was developed by researchers in Sweden.

Donatella Puglisi, associate professor at Linköping University, said: “We’re trying to mimic the mammalian sense of smell artificially.

“We’ve now developed an algorithm that can distinguish ovarian cancer from endometrial cancer and healthy control groups, using data from an electronic nose.

“More and more people are being diagnosed with cancer, especially young adults, and this is alarming.

“If screening were more accessible, both in terms of cost and location, it would be possible to improve early diagnosis.

“Our approach could facilitate the adoption of new screening protocols and the development of new diagnostic methods, improving survival rates, quality of life, and overall clinical outcomes.”

Electronic nose technology has existed for around 60 years.

The sensors used in the prototype are relatively simple models already available on the market, but recent advances in artificial intelligence and machine learning have enabled the technology to be used in new ways.

Current blood-based cancer screening typically involves searching for biomarkers specific to the suspected cancer.

However, researchers say these tests are often slow and lack accuracy.

Jens Eriksson, associate professor at Linköping University and chief technology officer at VOC Diagnostics AB, the company developing the electronic nose, said: “Unlike in breast cancer, there is currently no reliable ovarian cancer screening method.

“These tests are often based on a single biomarker and lack the precision required to detect the disease at an early stage.

“Our method is therefore far ahead not only in terms of accuracy but also in the ability to identify early disease.

“It’s a simple test that takes 10 minutes and gives a clear result. Our method can test many people at a low cost and is much more accurate than what’s on the market today.

“This study is a pilot, but we hope it will be used as part of cancer screening within three years. Right now, we’ve focused on detecting cancer, but the applications are endless.

Ovarian cancer often causes vague symptoms similar to those of more common conditions, meaning it is frequently diagnosed at a late stage when survival outcomes are poor.

In 2022, about 325,000 new cases and more than 200,000 deaths were reported globally, with estimates suggesting these figures will rise sharply by 2050.