MHRA approves Seagen’s oral HER2 drug Tukysa

The UK drugs regulator has approved Seagen’s Tukysa as a third-line treatment for HER2-positive breast cancer, shortly after it was given a green light by the European Commission. 

Tukysa (tucatinib) – an orally-active HER2 inhibitor – can be used in combination with anti-HER2 antibody trastuzumab and chemotherapy capecitabine in patients treated with two prior anti-HER2 regimens, according to the MHRA.

It’s the third oral HER2 drug to be approved for use in the UK and Europe, but could be the first with a chance to generate blockbuster sales, according to analysts.

As a result of Brexit, the MHRA approval applies to England, Scotland and Wales, while the European Commission has cleared use of the drug in Northern Ireland, which remains under its regulatory remit for the remainder of this year.

According to Seagen – known as Seattle Genetics until a name change last year – Tukysa is the first HER2 tyrosine kinase inhibitor shown to improve overall and progression-free survival (PFS) in previously treated HER2-positive breast cancer.

The approval is based on the HER2CLIMB study, which involved patients who had previously been treated with Roche’s trio of HER2 drugs Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine).

The Tukysa arm demonstrated an improvement in overall survival, with a 34% reduction in the risk of death compared to trastuzumab and capecitabine alone.

In addition, out of the 47% of patients whose cancer had spread to the brain in the study, Seagen’s drug cut the risk of disease progression or death by 52%, thanks to its ability to cross the blood-brain barrier and penetrate the central nervous system.

Seagen’s chief executive Clay Siegall said the company will now “look forward to further collaborating with the national reimbursement bodies to ensure it is available to adult patients” in the UK.

The first oral HER2 drug to reach the market was Novartis’ Tyverb (lapatinib), which is generally reserved for use after HER2 and chemotherapy-based treatment has failed, and is a minor product in Novartis’ oncology portfolio.

Tyverb – known as Tykerb in the US – was followed a couple of years by Puma Biotech/Pierre Fabre’s Nerlynx (neratinib), which is also approved for a different indication. The drug is given as an adjuvant therapy after surgery for early-stage HER2-positive breast cancer to reduce the risk of the disease coming back, and made around $211 million in revenues for Puma last year.

Tukysa was approved by the FDA almost a year ago, and at that time analysts at Leerink predicted sales of the drug could reach $1.6 billion thanks to wording on the US label that allowed second- or third-line use of the drug.

They reckon that Tukysa’s ability to treat tumours that have spread to the brain will help it capture market share from Kadcyla, a go-to second-line therapy.

Seagen is already running trials to expand the use of the drug into earlier lines of breast cancer therapy – including adjuvant and neoadjuvant use – as well as in other solid tumours including colorectal cancer.

The post MHRA approves Seagen’s oral HER2 drug Tukysa appeared first on .

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer


  • The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery)
  • Result of FeDeriCa Study: The GMR for the 1EPs (1.22) with the lower limit (90%) CI of the GMR (1.14≥0.80). 2EPs of non-inferior levels of Herceptin was also met with blood conc. GMR (1.33) with the lower limit (90%)
  • Phesgo combines the same mAb as Perjeta and Herceptin with Halozyme Therapeutics Enhanze drug delivery technology in a novel formulation for SC use

Click here ­to­ read full press release/ article | Ref: Roche  | Image: Fierce Biotech

The post Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer first appeared on PharmaShots.

Roche claims EU okay for Herceptin/Perjeta combination Phesgo

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides a defence against biosimilar competition.

Phesgo combines the anti-HER2 antibodies in Herceptin (trastuzumab) and Perjeta (pertuzumab) in a subcutaneous injection that takes a few minutes to deliver.

At the moment, Herceptin is available as a subcutaneous injection but Perjeta needs to be delivered by intravenous infusion – a process that takes hours – and Roche says that means Phesgo is preferred by both patients and doctors and also reduces the cost of treatment.

Phesgo has been approved by the EU for same indications as Herceptin/Perjeta – in combination with chemotherapy in early HER2-positive breast cancer (pre- and post-surgery) as well as for front-line therapy of HER2-positive breast cancer that has already spread in the body.

The drug was cleared by the FDA in June for the US market and made CHF 7 million (almost $8 million) in preliminary sales in the third quarter, with Roche still in the process of securing formulary approvals.

That’s a drop in the ocean compared to the CHF 1.5 billion and CHF 910 million in Herceptin and Perjeta sales, respectively, in the same period, but with Phesgo Roche is looking to the future.

Herceptin sales dropped a third in the first nine months of the year due in part to the pandemic but mainly the impact of low-cost biosimilars, although Perjeta remains in-patent for the next few years and is growing fast – thanks largely to data from the APHINITY trial which showed that adding it to Herceptin can improve disease-free survival in early-stage breast cancer.

That makes Perjeta a particularly important part of Roche’s product range, particularly as two of its other big-selling antibodies – Avastin (bevacizumab) and Rituxan/MabThera (rituximab) – are also being hit by biosimilar competition.

As many patients with HER2-positive breast cancer received the drug in combination with Perjeta, the convenience of Phesgo is a big draw – patients can be in and out of clinic in 30 minutes rather than three hours or more.

It remains to be seen of course whether payers can be convinced to plump for the new drug over biosimilar trastuzumab plus Perjeta, allowing the drug to mitigate the impact of Herceptin biosimilars on Roche’s HER2 franchise.

“The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives,” said Levi Garraway, Roche’s chief medical officer.

“It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.”

After the US approval, Piper Sandler analyst Joseph Catanzaro said that Phesgo could be an underappreciated blockbuster product that will be a growth driver for Halozyme, the company that provided the drug delivery technology that underpins the new product.

The post Roche claims EU okay for Herceptin/Perjeta combination Phesgo appeared first on .