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.

A baby boy is the first in the UK to be born after a womb transplant from a deceased donor, a development doctors say could offer hope to women born without a womb.

Grace Bell, in her 30s and from Kent, was born with MRKH syndrome, a condition in which a woman is born without a viable womb. She does not have periods but has normal ovaries.

At 16, she was told she would not be able to carry her own child.

As reported by the BBC, Bell’s womb transplant took 10 hours and was carried out at The Churchill Hospital in Oxford in June 2024.

Several months later, the couple underwent IVF treatment, followed by embryo transfer, at The Lister Fertility Clinic in London.

Her son, Hugo, was born just before Christmas 2025 at Queen Charlotte’s and Chelsea Hospital in west London, weighing nearly 7lbs. He is now 10 weeks old.

Bell said: “It was simply a miracle. I remember waking up in the morning and seeing his little face, with his little dummy in, and it felt like I needed to wake up from a dream.

“It was just incredible.”

Bell and her partner Steve Powell paid tribute to the donor and her family.

Bell said: “I think of my donor and her family every day and pray they find some peace in knowing their daughter gave me the biggest gift: the gift of life. A part of her will live on forever.”

The successful transplant is one of 10 deceased donor womb transplants taking place as part of a UK clinical research trial.

Three have already been carried out, but Hugo is the first baby born.

In early 2025, a baby called Amy was born through the first living womb donation in the UK, at the same London hospital.

Her mother received her older sister’s womb in a transplant operation in January 2023. Five further womb transplants from close living relatives are planned.

Consultant gynaecologist Prof Richard Smith, from Imperial College Healthcare NHS Trust, who began researching womb transplantation more than 25 years ago and was present at Hugo’s birth, said “a huge team of people” had been involved, from the transplant operation to embryo transfer and delivery.

Bell and Powell gave their son the middle name Richard in tribute to Smith, who also founded the charity Womb Transplant UK.

The couple may decide to have a second baby, after which surgeons plan to remove the transplanted womb.

This is to spare Bell from taking a lifetime of strong drugs to prevent the immune system attacking the transplanted organ.

Transplant surgeon and joint team leader Isabel Quiroga said she was “delighted” by Hugo’s birth and described it as a breakthrough for organ transplantation in the UK.

“Very few babies have been born in Europe as a result of their mothers receiving a womb from a deceased donor,” she said.

“Our trial is seeking to discover whether this procedure could become an approved and regular treatment for some of the increasing number of women of child-bearing age who do not have a viable womb.

Smith said the birth showed that girls and young women told they did not have a womb could now have hope of carrying their own child.

A baby born following a womb transplant from a deceased donor has no genetic link to the donor.

More than 100 womb transplant operations have been performed worldwide and more than 70 healthy babies have been born as a result.

Donating a womb for transplant differs from donating other organs, such as kidneys or a heart, as it requires a specific request to families who have already agreed to organ donation.

The donor’s parents, who wish to remain anonymous, said they felt “tremendous pride” in the legacy left by their daughter. She also donated five other organs, which were transplanted into four people.

“Through organ donation, she has given other families the precious gift of time, hope, healing and now life,” her family said.

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.