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Bayer bags speedy US approval for lymphoma drug Aliqopa

FDA decision sets the pharma firm up for a showdown with Gilead's Zydelig

Bayer

The FDA has approved Bayer's PI3K inhibitor Aliqopa, setting up a market showdown with Gilead Sciences' Zydelig in follicular lymphoma.

Aliqopa (copanlisib) has been given a conditional green light as a third-line treatment for patients with relapsed or refractory follicular lymphoma, the most common type of non-Hodgkin's lymphoma (NHL), and Bayer has committed to carrying out additional studies to confirm its benefits in this setting.

Richard Pazdur, director of the FDA's Office of Haematology and Oncology Products, said: "For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments.

"Options are limited for these patients and today's approval provides an additional choice for treatment, filling an unmet need for them."

Aliqopa has been approved on the back of the phase II CHRONOS-1 trial, which showed that Bayer's drug achieved a complete or partial response in 59% of patients, with a median response duration of 12.2 months.

Zydelig (idelalisib) – the first-in-class PI3k inhibitor – is approved for relapsed follicular lymphoma and also chronic lymphocytic leukaemia, but saw its commercial prospects scuppered last year after reports of serious side effects, and some deaths, in clinical trials involving treatment-naïve lymphoma and leukaemia patients.

Sales had never really gathered much momentum and slid in the first half of the year to $70m, down from $90m a year earlier. At one point, Zydelig had been expected to become a $1bn-plus blockbuster, but that mantle has now been inherited by Johnson & Johnson's BTK inhibitor Imbruvica (ibrutinib) which has become dominant in first-line CLL and NHL therapy.

Zydelig is an oral therapy, while Aliqopa is given as a one-hour infusion on an intermittent weekly basis - three weeks on and one week off, but Bayer says that in this patient group that is not an impediment and actually fits in well with care of these patients.

The company has predicted sales could top $500m, and some analysts think it could go higher than that if it also claims approval as a second-line therapy for NHL in combination with rituximab as well as other cancers. It may face additional competition in the not-too-distant future, however, with other P13K inhibitors such as TG Therapeutics' TGR-1202 and Verastem's duvelisib coming through clinical development.

Meawhile, Bayer is also developing its drug for breast cancer and other solid tumours, but in the non-haematological sphere Novartis' P13K alpha inhibitor alpelisib is in pole position, with phase III trials for breast cancer and phase II in non-small cell lung cancer (NSCLC) with a filing due in 2019.

15th September 2017

From: Regulatory

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