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Global New Drug R&D express:POSLUMA, Tildrakizumab, repotrectinib, INBRX-101

1 U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA® (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer

Blue Earth Diagnostics announced FDA approval for its rhPSMA-targeted PET imaging agent, POSLUMA® (flotufolastat F 18) injection. It is the first and only FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid (rh) technology. The approval is based on data from two Phase 3 trials (LIGHTHOUSE and SPOTLIGHT). Results from the LIGHTHOUSE study demonstrated high specificity for the detection of pelvic lymph nodes as compared to histopathology standard of truth in men with PSMA-positive lesions prior to radical prostatectomy. The SPOTLIGHT study demonstrated high detection rates (% positive PET scans) even at low PSA levels in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy.

2 China Medical System Announced New Drug Application of Tildrakizumab Injection Approved in China

China Medical System announced that the NDA of Tildrakizumab Injection has been approved by the China NMPA. ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The results of the extended study of Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance. ILUMETRI only requires 4 administrations per year over maintenance period, which may result in higher patient compliance.

3 U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

Bristol Myers Squibb announced that the FDA has accepted the NDA for repotrectinib for the treatment of patients with ROS1-positive locally advanced or metastatic NSCLC. The FDA granted the application Priority Review and assigned a PDUFA goal date of November 27, 2023. The filing was based on results from the TRIDENT-1 study. In the trial, repotrectinib demonstrated high response rates and clinically meaningful durability of benefit in both TKI-naïve and TKI-pretreated patients, including those with ROS1 resistance mutations.

4 Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial

Pfizer announced that the pivotal Phase 3 BASIS clinical trial (NCT03938792) of marstacimab for hemophilia A or B has met its primary endpoints. The BASIS trial demonstrated that prophylactic treatment with marstacimab resulted in a statistically significant and clinically relevant reduction in ABR in people living with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors. In the cohort of patients treated with on-demand factor replacement intravenous therapy in the lead-in period, marstacimab demonstrated superiority (P< 0.0001) with a 92% reduction in bleeds. The results also showed superiority (p=0.0376) with marstacimab compared to prophylaxis, with a 35% reduction in ABR.

5 Inhibrx Granted Fast Track Designation for INBRX-101 for the Treatment of Alpha-1 Antitrypsin Deficiency

Inhibrx announced today that the FDA granted Fast Track designation to INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency (AATD). INBRX-101 is being evaluated in a randomized, controlled, double-blind, head-to-head superiority, registration-enabling trial, and the initial read-out from the trial is expected to occur in late 2024.

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