November has 4 FDA approvals so far. Most recently, the FDA approved Jazz Pharmaceuticals & Zymeworks’ Ziihera (zanidatamab) and Autolus’ Aucatzyl® (obecabtagene autoleucel). AstraZeneca’s AdComm for Andexxa is scheduled today with the FDA raising safety concerns ahead of the meeting.Want to learn about upcoming Adcoms and PDUFAs? Check out our free BiopharmIQ PDUFA calendar. Read more below about these recently approved therapies and new indications.
FIG 1. November PDUFA Calendar
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Jazz Pharmaceuticals & Zymeworks PDUFA for Ziihera (zanidatamab) - APPROVED
» For adults with previously treated, HER2-positive biliary tract cancer
» First & only dual HER2-targeted bispecific antibody approved
» Accelerated approval based on HERIZON-BTC-01 trial 🧪
52% ORR & 14.9-month median DOR
Ph3 HERIZON-BTC-302 confirmatory trial ongoing
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Autolus PDUFA for Aucatzyl® (obecabtagene autoleucel) - APPROVED
» For adult B-cell acute lymphoblastic leukemia (r/r B-ALL)
» The first CAR T therapy approved with no required REMS program 👏
» Approval based on FELIX trial in adult patients with r/r B-ALL 🧑🔬
63% overall complete remission (OCR)
42% complete remission within 3 months
Median duration of remission: 14.1 months
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Syndax PDUFA for Revuforj® (revumenib) - APPROVED
» The first & only menin inhibitor for relapsed or refractory (R/R) acute leukemia with KMT2A translocation 🩸
» Based on AUGMENT-101 trial
robust and durable rates of remission 💯
» Syndax plans to launch Revuforj this month 🚀
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PTC Therapeutics for Kebilidi™ - APPROVED
» For AADC deficiency
» 1st-ever approval for gene tx directly administered to the brain 🧠
» rAAV2-based gene tx 🧬🚗
» Broad label including children and adults 📈
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AstraZeneca AdComm for Andexxa (coagulation factor Xa [recombinant], inactivated -zhzo) - AdComm
» Adcomm: 11/21/24
» for patients treated w/ rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding 🩸
⚠️ Ahead of meeting, FDA raised safety concerns:
» Increased rates of dangerous clotting & clotting-related deaths
» Uncertainty about clinical meaningfulness of the benefit & whether it outweighs risks 🤔
» No vote scheduled, but the committee's input will be crucial for FDA's decision-making.
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Want to schedule a demo of how to use our online platform to search for upcoming PDUFAs or clinical trial dates, combined with targeted sponsor info searching? You can even set up an alert any time a new PDUFA date is set.
Contact marketing@biopharmiq.com
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Article History:
MV/JD/RF/AV (11/21/24)
Not legal, investing, or tax advice.
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