World Pharmacy

The addition of ovarian suppression to adjuvant tamoxifen significantly improved the rates of DFS and overall survival versus tamoxifen alone at 8 years, according to results from the joint analysis. The risk of recurrence was further reduced when exemestane was used in combination with ovarian suppression. Although the analysis confirmed that women with high-risk features require an LHRH inhibitor plus an aromatase inhibitor (AI), results of a subset analysis revealed that tamoxifen alone may be sufficient for women with low-risk disease.

“We’re beginning to be able to personalize therapy for premenopausal women,” said O’Shaughnessy, co-chair of Breast Cancer Research and chair of Breast Cancer Prevention Research at Baylor-Sammons Cancer Center, Texas Oncology. “This is critically important because endocrine therapy for premenopausal estrogen receptor (ER)–positive women is by far the most important therapy.”

In an interview during the 2019 OncLive^® State of the Science Summit™ on Breast Cancer, O’Shaughnessy, also chair of The US Oncology Network and a 2016 Giant of Cancer Care^® in Community Outreach, discussed the clinical implications of the TEXT and SOFT trials for women with premenopausal HR-positive, HER2-negative breast cancer, as well as unanswered questions that remain with adjuvant endocrine therapy.

Zydus Cadila has received the final approval from the USFDA to market Exemestane Tablets, (US RLD – AROMASIN Tablets), 25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

The estimated sale for Exemestane Tablets is $68.6 million (Source: IMS Health, IMS National Sales Perspective Audit, MAT August 2018, extracted September 2018.)

Exemestane belongs to the group of medicines called aromatase inhibitor. It is used in women after menopause for the treatment of early breast cancer in women who have cancer that needs the female hormone estrogen to grow, have had other treatments for breast cancer for 2-3 years and are switching to Exemestane to complete 5 years in a row of hormonal therapy.

It is also used in the treatment of advanced breast cancer after treatment with other therapies, where it has not benefitted the patient or is no longer effective.

The group now has 220 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

A new drug combo has been made available to some patients with advanced breast cancer on the NHS in England.

The National Institute for Health and Care Excellence has recommended the drugs – called abemaciclib (Verzenio) and fulvestrant (Faslodex) – in new draft guidance, after the treatments were shown to slow disease progression and delay the need for chemotherapy in a clinical trial.

NICE said the combo could be an option for up to 4,800 women. This would include patients whose breast cancer has spread and who have already had hormone therapy. Patients’ cancer cells would need to test positive for certain hormone receptors, but not the HER2 receptor.

The treatment combo will only be used where the alternative would be a combination of two other drugs, a hormone therapy called exemestane (Aromasin) and the targeted drug everolimus (Afinitor).

Rose Gray, policy manager at Cancer Research UK, called the decision “great news.”

“Clinical trials showed promising results, with this treatment giving patients more time before their disease gets worse which is important,” she said.

Long-term data needed

Abemaciclib is a targeted cancer drug that works by blocking growth molecules inside cancer cells, which stops them from dividing. It’s been tested in combination with the hormone treatment fulvestrant.

In a trial involving 669 patients with advanced breast cancer, taking a combination of abemaciclib and fulvestrant increased the time before patients’ cancers got worse, compared to taking fulvestrant alone.

Patients taking the drug combo were alive for an average of 16.5 months without their cancer getting worse, compared to 9.3 months for those just taking fulvestrant.

But serious side effects were more common in the group taking the drug combination, with 1 in 5 people experiencing side effects including severe diarrhoea and blood clots.

The trial has not been running for long enough to know how much the drug combination will improve long-term survival for these patients.

“Because this treatment is so new, we don’t yet know how well patients do in the long term – but this drug has been approved through the Cancer Drugs Fund, which means patients can access the drug quickly while more data is collected about its longer-term benefits,” said Gray

The Cancer Drugs Fund gives patients access to new treatments before they are approved for routine use in the NHS. This gives the NHS and the drug company time to collect more data on the long-term benefits of the drug.

The drug combination will stay on the Cancer Drugs Fund while the final results of the clinical trial are collected, which is expected to be in February 2020, at which point NICE will decide whether the NHS should continue to fund the treatment.

Improving quality of life

Meindert Boysen, director of the centre for health technology assessment at NICE, said the committee heard from patients that treatments that postpone or avoid the need for chemotherapy are important and could improve quality of life.

“They also highlighted the importance of people remaining in better health longer, without the disease progressing,” he said.