Response to Fleximab Advertising/Promotion System (APS)
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The PAABPharma Canada Inc. Fleximab Advertising/Promotion System (APS) listed below, received in English on October 26, 2023, has been reviewed. PAAB comments follow:
- Page 1: Subject line -- The multiple subject lines suggest this is an inerative submission. Please see Guidance on Submission Process and Format Requirements on required submission for this type of APS or remove multiple subject lines.
Further, "See why you should prescribe Fleximab to your patients with NSCLC" has the product name and indication without indication statement present. (s 2.10.1) .
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Page 1: Subject lines See results of Fleximab in Study Y; PFS results in Study Y do not include cited study in TMA. Please revise. (
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Page 1: Flash. The First in Class statement should include full statement from Mechanism of Action section of the TMA. As well, current layout appears that this claim is in the same section as a theraputic claim. Please revise (s 2.6)
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Page 1: The molecule name is missing from first reference of the therapy (s. 2.2). Please revise.
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Page 1: Visual - We caution that the visuals used in the APS may convey messages which may change the interpretation of the piece to be for populations not within the TMA. (2.10)
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Page 1: Header FLEXimab demonstrated efficacy in PFS creates an absoulte statement and may appear in layout without trial desgin statement. Please revise (s 2.6)
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Page 1: Body copy: "The Discover how FLEXimab can benefit your patients with NSCLS". This is future tense and is not supported. Please include outcome supported in the TMA (s2.6)
8: Page 1: Body "The FLEX Trial demonstrated statistically significant improvement in PFS for patients on FLEXimab as compared with chemotherapy" does not have supporting references (s 1.4.i)
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Page 1: Call to Action: The APS is unclear if the direction to learn more is about a future study that has not been published or other promotional activities. Please revise.
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Page 1: Headline: FLEXimab provides a low 14.5% anemia risk suggests a promotional use of a adverse effect and the percentage does not match the TMA. As well, the layout of the APS means the full adverse event table may not be seen. Please revise. (s2.4)
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Page 1: Subhead: Well-established safety profile is incomplete (s.2.1) and requires the most common side effects.
12: Page 2: We question the use of FLEX in the dosing statement as it suggests a unsupported benefit of the therapy. s(2.1)
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Page 2. Visual: The calendar visual overpromises the benefit of the therapy (i.e., running a marathon) and suggets population not supported by the TMA. (s2.1)
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Page 2. Callout: Give your patients more time and money with oral dosing #FLEXtime is unsubstatiated and makes a benefit beyond the TMA. (s 2.6)
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Page 3: Copy: [Copy]: Encourage them to share their story Plese provide efile of linked out social media sites. Further comments may arise.
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Page 4: Safety information should appear closer to efficacy statements and layout may not be seen by all viewers of the email (s2.4.1)