Update for February 8, 2022

New Drugs Added to Knowledgebase
 
Last week we added 10 new drugs to the knowledgebase:

• Modakafusp alfa an anti-CD38-targeted IgG4-attenuated interferon alpha for the treatment of multiple myeloma
• TT11 a CAR-T cell Therapy for the treatment of Hodgkin lymphoma
• FT516 a natural killer cell therapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
• FT596 a natural killer cell therapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma, relapsed or refractory chronic lymphocytic leukemia
• Lazertinib a EGFR TKI for the treatment of non-small cell lung cancer (NSCLC) and EGFR exon 19 deletion or L858R mutations
• Allogeneic retinal pigment epithelium (RPE) cells a cell replacement therapy for the treatment of age-related macular degeneration (AMD) with geographic atrophy
• Lirentelimab a monoclonal antibody for the siglec-8 receptor for the treatment of eosinophilic gastritis, eosinophilic duodenitis, atopic dermatitis, chronic spontaneous urticaria, and asthma
• Patritumab (HER3-DXd) an antibody drug conjugate (ADC) for the treatment of metastatic EGFR-Mutated non-small cell lung cancer (NSCLC)
• Teclistamab a bispecific antibody for the treatment of relapsed or refractory multiple myeloma
• Acoramidis a TTR stabilizer for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) and transthyretin amyloid polyneuropathy (ATTR-PN)​

The Prescribe Right Pharmaceutical Pipeline Tracker now allows you to track 990 pipeline and recently approved drugs supported by 2,396 announced and published study results.
 
Regulatory Update
 
The FDA approved sutimlimab (Enjaymo, Sanofi), on 2/4/2022, to decrease the need for red blood cell transfusions due to hemolysis in cold agglutinin disease.
 
The FDA designated CardiAMP (autologous mesenchymal stem cells), a Breakthrough Therapy for the treatment of heart failure.
 
Harpreet Singha and Richard Pazdura, of the FDA’s Oncology Center of Excellence, published an editorial in Lancet Oncology describing how current submissions for new drugs developed in China are only including data from trials only conducted in China. They question whether the data represents a broad enough patient sample for the U.S. population. They recommend use of multiregional clinical trials, which have been used for more than 20 years, to evaluate an investigational drug submitted to the FDA.
 
Announced Research Updates
 
Pharming announced that in a 12-week, 31 patient, Phase II/III trial, treatment with leniolisib resulted in a reduction in lymphadenopathy lesions and an increase in B cells in patients with Activated pI3Kdelta syndrome (APDS). 
 
Vanda announced that in a 12-week, Phase III trial, treatment with tradipitant did not decrease the daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary compared to placebo in patients with gastroparesis.
 
Published Research Updates
 
In the 16-week, 98 patient, Phase III, THUNDER trial, treatment with fevipiprant did not improve the nasal polyp score compared to placebo in asthma patients with chronic rhinosinusitis with nasal polyps.
 
In a 30-month, 201 patient, Phase IIb trial, 46% of patients treated with probiotic and peanut oral immunotherapy (PPOIT) and 51% of patients who received only peanut immunotherapy (OIT) achieved 8-week sustained responsiveness after 18 months of treatment compared to 5% with placebo in Australian pediatric patients with peanut allergy. There was no difference between patients that received PPOIT or OIT.

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