Drug Approvals

I have worked on the six new investigational compounds which have been approved by the FDA. My contributions to the approval of these treatments includes authoring submission components for five of the submissions.

 

daurismo-logoDAURISMO® (glasdegib)
FDA approval: December 2018
Indication:For use in combination treatment of adult patients ≥75 years with newly-diagnosed acute myeloid leukemia (AML).
Contribution: I authored the PK-QTc analysis report included in the submission.

 

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VIZIMPRO® (dacomitinib)
FDA approval: September 2018
Indication: First-line EGFR-mutant non small cell lung cancer
Vizimpro (dacomitinib) is an oral, once-daily, irreversible pan-human epidermal growth factor receptor tyrosine kinase inhibitor (TKI) indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
Contributions: I authored the Adverse Event PK/PD exposure response analysis report included in the submission.
I authored a PK/PD exposure response analysis report on the tumor size over time using a tumor growth inhibition model and a PK/PD exposure response analysis report modeling the occurrence of dose-altering AEs and the effect of a 30 mg QD versus a 45 mg QD dosing regimen on tumor size in response to a query from the FDA.

 

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LORBRENA® (lorlatinib)
FDA Approval: August 2018
Indication: Anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on: crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Contribution: I authored the QTc/PR analysis report included in the NDA.
I was the Clinician for the mass balance study B7461004 as well as the co-clinical pharmacology lead for the Phase 3 study comparing lorlatinib versus crizotinib in first line ALK-positive non-small cell lung cancer from protocol development through full enrollment.

 

mylotarg-logoMYLOTARG® (gemtuzumab ozogamicin)
FDA Approval: September 2017
Indications: Adults with newly-diagnosed CD33-positive acute myeloid leukemia (AML). Adults and children 2 years and older with relapsed or refractory CD33-positive AML.
Contributions: I authored a PK/PD exposure response analysis of safety and efficacy report included in the submisison. I was the lead author on the manuscript covering the PK/PD analyses which was accepted by the journal: Clinical Pharmacology and Therapeutics.

 

besponsa-logo BESPONSA® (inotuzumab ozogamicin)
FDA Approval: August 2017
Indication: adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Contribution: I authored a PK/PD exposure response analysis evaluating efficacy and safety. This report was not included in the submission, but the results were presented in a manuscript in Blood Advances.

 

Bavencio-logoBAVENCIO® (avelumab)
FDA Approval: March 2017
Indications: avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma.
Contribution: I authored a PK/PD exposure response analysis report on efficacy (OR, PFS, and OS) included in the submission.