ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
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.
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 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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05568966 |
Collection of Blood Samples for New Diagnostic Devices 2 |
RECRUITING | NA |
| NCT01054261 |
To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function. |
COMPLETED | PHASE1 |
| NCT00972205 |
Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors |
COMPLETED | NA |
| NCT00423254 |
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer. |
COMPLETED | PHASE1 |
