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NCE-1 Intelligence & Market Opportunity

Exkivity

Mobocertinib
Anticancer
Oral Capsule

EGFR exon 20 insertion lung cancer briefly had two targeted options approved within months of each other. Exkivity (mobocertinib) was the oral one, and it did not last.

Designed to bind the altered EGFR conformation these insertions produce, the once-daily oral inhibitor held accelerated approval for locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations after platinum-based chemotherapy.

Takeda voluntarily withdrew Exkivity from the U.S. market in 2023 after the confirmatory EXCLAIM-2 trial failed to show a progression-free survival benefit over platinum chemotherapy. Its withdrawal left Rybrevant as the principal targeted option in the indication.

Approval Date
15-Sep-21
NCE-1 Date
15-Sep-25
NCE Date
15-Sep-26
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
NA
2027
NA
2028
NA
2029
NA
2030
NA
2031
NA
2032
NA
Molecule profile

Details & specifications

Molecule
Mobocertinib
Innovator
TAKEDA PHARMS USA
Dosage Form
Oral Capsule
Strength
EQ 40 mg base
Therapeutic Category
Anticancer
Usage
To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
Good to know

Frequently asked questions

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