Takeda to chase Roche in ALK targeted therapy market

Alecensa tops the market, Alunbrig to receive reimbursement for first-line therapy this year

Xalcori-maker Pfizer to launch a third generation new drug this year

Product images of ALK-positive treatment.

 

Clockwise from left: Xalkori, Zykadia, Alunbrig and Alecensa

The follow-on drug competition within the anaplastic lymphoma kinase (ALK)-positive lung cancer treatment market is intensifying with more competitors joining the race.

 

From next month, Alunbrig (brigatinib), receiving the National Health Insurance (NHI) reimbursement for the first-line therapy for lung cancer, and the market leader Alecensa (alectinib) are to engage in a fierce competition.

 

On top of everything else, a third-generation new drug following after Xalkori (crizotinib) is to be introduced.

 

The ALK-targeting treatment market has been dominated by Pfizer Pharmaceutical Korea’s Xalkori so far.

 

As a first-generation ALK tyrosine kinase inhibitor (TKI), it has been generating 50 billion won annually in sales.

 

Like the epidermal growth factor receptor (EGFR) targeted therapy market, ALK TKI market has been reshuffled since second generation drugs were released to the market.

 

Particularly, Roche’s Alecensa has been strongly asserting its market presence as soon as it entered the market.

 

Alecensa, approved as a third ALK targeted therapy in South Korea in 2016, has expanded its indication to treat ALK-positive patients with non-small cell lung cancer (NSCLC) as a first-line therapy in April 2018, and requested for the reimbursement listing in December of the year.

 

Immediately after getting listed for the first-line therapy indication, Alecensa sales exceeded Xalkori’s.

 

In 2018, Alecensa sales hit 10.4 billion won, or a quarter of Xalkori’s at 49.6 billion won, but after the listing in 2019, the drug generated 22.1 billion and surpassed Xalcori making 20.3 billion won.

 

Technically, Alecensa took over a half of Xalkori’s market share.

 

Even last year, Alecensa made 29.3 billion won and topped the ALK treatment market.

 

Regardless, even Alecensa is to face another new comer.

 

Takeda Pharmaceuticals’ Alunbrig is swiftly prepping to overtake Alecensa’s place.

 

As a fourth ALK TKI drug in South Korea, Alunbrig was authorized in December 2018.

 

In the following year, the drug was released in the second quarter and raised 1.2 billion won.

 

Takeda Pharmaceuticals is speeding up the drug’s marketing procedure as it started late as a second generation drug.

 

The multinational company has immediately requested for the reimbursement as soon as Alunbrig’s expanded indication for the first-line therapy was cleared in last August.

 

The drug has been passed by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation convened last January.

 

The drug is expected to win the coverage for the first-line therapy within the first half of the year at earliest.

 

Alunbrig is the first solid cancer treatment Takeda Pharmaceuticals launched.

 

Backed by the company’s big ambition, the drug sales generated 3.9 billion won in 2020, which fell short of Alecensa and Xalkori’s, but it is looking forward to rapidly grow in the market with the first-line therapy expansion.

 

Moreover, the market is going to open a door to a third generation ALK TKI new drug this year as well.

 

Pfizer Pharmaceutical that developed Xalkori is preparing to launch Lorbrena (lorlatinib).

 

Submitting the approval application last year, Pfizer is currently in process of reviewing Lorbrena with South Korea’s Ministry of Food and Drug Safety (MFDS).

 

Lorbrena is also to accelerate the expansion to the first-line therapy.

 

Already in the U.S., the drug successfully won the first-line therapy indication as of Mar.

 

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Categorized as a third generation drug, Lorbrena can reportedly cover more resistance gene mutations.

 

Meanwhile, Novartis’ Zykadia (ceritinib) was quickly introduced to the market, the prescription market seems to be disinterested in the drug.

 

Zykadia has raised 800 million won in sales, which was lower than Alunbrig’s that entered the market last.