ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
ImmunityBio reported a fivefold revenue increase to $38.29 million, driven by a 750% surge in unit sales of its cancer drug Anktiva. The company is expanding internationally through partnerships in the Middle East and preparing additional FDA submissions for Anktiva's broader use.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
The FDA has approved Novocure's Optune Pax device for locally advanced pancreatic cancer, marking the first new treatment for this patient group in decades. A trial of 571 patients showed a two-month improvement in overall survival when combined with chemotherapy.
The FDA approved Novocure's Optune Pax device for locally advanced pancreatic cancer treatment alongside chemotherapy, marking the first new treatment option in this indication since 1996. Phase III trial data showed statistically significant survival improvement.
The FDA approved Optune Pax, a wearable Tumor Treating Fields device, for locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel. The approval marks the first new treatment for this indication in nearly 30 years.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
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|---|---|---|---|
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COMPLETED | |
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WITHDRAWN | PHASE2 |
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| NCT06060613 |
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