AstraZeneca v Novartis: Femara subgroup charts and “entire spectrum” press claim found misleading on appeal (AUTH/1915/11/06)

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Key facts

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Case number	AUTH/1915/11/06
Parties	AstraZeneca v Novartis Pharmaceuticals UK Ltd
Product	Femara (letrozole)
Materials	Leavepiece (ref FEM 05000083) and press release
Complaint received	10 November 2006
Case completed	13 March 2007
Applicable Code year	2006
Main issues	Implied increased benefit in node-positive and prior-chemotherapy subgroups; broad licensing claim “across the entire breast cancer treatment spectrum”; safety omission allegation (bone mineral density) not upheld
Key study referenced	BIG 1-98
Final breach findings	four breaches of 7.2, four of 7.3 and breach of 7.4, three breaches of 7.10 and breach of 20.2
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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AstraZeneca complained about a Novartis promotional leavepiece for Femara (letrozole) (ref FEM 05000083) and a Novartis press release.
The leavepiece used BIG 1-98 disease-free survival (DFS) data, showing overall 19% fewer recurrences (p=0.003) and larger-arrow bar charts for subgroups: 29% fewer recurrences in node-positive women (p=0.0002) and 28% fewer recurrences in women with previous chemotherapy (p=0.02).
AstraZeneca alleged the subgroup-focused claims were misleading/unbalanced and could encourage broader use based on perceived “greater potency” in higher-risk groups.
AstraZeneca also alleged the leavepiece lacked adequate safety statements in the main body (eg bone mineral density reduction/fracture risk), despite stating “Overall FEMARA was generally well tolerated compared with tamoxifen”.
The press release claimed: “Femara is now the first and only [aromatase inhibitor] licensed for treatment across the entire breast cancer treatment spectrum…”. AstraZeneca said “entire” was misleading because Femara was not licensed for adjuvant switch (within five years of surgery, switching from tamoxifen).
The Panel initially ruled no breach for the subgroup claims and the safety omission point; AstraZeneca appealed the subgroup rulings.

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Leavepiece subgroup claims: On appeal, the Appeal Board ruled the presentation implied increased benefit in node-positive and prior-chemotherapy subgroups versus the overall population; such additional benefit was unproven given the statistical context (forest plot overlap; no correction for multiple subgroup analyses). Breaches were ruled on appeal.
Leavepiece safety statement allegation: The Panel ruled no breach; side effects were in prescribing information and omission of bone mineral density warning in the main body was not considered misleading or an inadequate benefit/risk profile. (Not appealed.)
Press release “entire spectrum” claim: The Panel ruled the claim misleading and not capable of substantiation because Femara was not licensed across the entire spectrum (not licensed for adjuvant switch). Breaches were ruled.

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