I am passionate about improving the lives of cancer patients by helping the pharmaceutical industry work with scientific, medical, and clinical experts.
Merck's oral MET inhibitor, #Tepotinib, receives FDA BTD status for the treatment of metastatic #NSCLC patients with specific MET alterations. Although only 3-5% of patients have such alterations, such targeted approach could be both clinically and commercially successful.
FDA grants accelerated approval to pembrolizumab (KEYTRUDA, Merck) in combination w/chemotherapy for treatment of patients w/ locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1. #bcsm
https://t.co/l8Jlu8YBkh
FDA approved azacitidine tablets (ONUREG, Celgene) for treatment of patients with acute myeloid leukemia who achieved 1st CR/CR w/incomplete blood count recovery following intensive induction chemotherapy & unable to complete intensive curative therapy https://t.co/wIodCNdmRK
PD-L1/CTLA4 struggle in prostate cancer. Low PD-L1, TMB and CD8 mean responses are rare. Shape of KM curves suggest CTLA4 and PD-L1 are not the same or is combining with enza the issue. Highly selected approach needed with different combos for success. https://t.co/7Nxjndvmk6
International regulators agree on acceptable endpoints for clinical trials for the development of #COVID19 treatments at the second #ICMRA global regulatory workshop on COVID-19 therapeutics. See the summary report ➡️https://t.co/eGSftKpi9f
FDA issued final guidance on the use of pathological complete response (pCR) in high-risk early-stage breast cancer as a potential endpoint to support approval under the accelerated approval regulations. #bcsm https://t.co/C8V8Kn46AL
FDA approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
#melsm
https://t.co/VPhMEqRhQg
We're getting ready to welcome you online tomorrow, July 17, for the FDA-@ASCO Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop! #OCEOutcomes20
https://t.co/3enSk3mxkB
The Oncologic Drugs Advisory Committee voted 12-0 in favor of the question: Does the demonstrated benefit of belantamab mafodotin outweigh the risks in the proposed patient population with multiple myeloma?
#FDAODAC
FDA Oncologic Drugs Advisory Committee #FDAODAC to meet online July 14, 9a-1:30p to discuss BLA 761158 belantamab mafodotin (GlaxoSmithKline) proposed for relapsed/refractory multiple #myeloma.
Webcast: https://t.co/TvG2pcRe9u
Meeting info & materials: https://t.co/MryBqEC2is
FDA today published 4 final guidances on #cancer#clinicaltrial eligibility criteria, describing ways that drug sponsors can safely and effectively include patients who historically have been excluded from trials. https://t.co/ZqlSyx93W2
FDA approved avelumab (BAVENCIO, EMD Serono) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with 1st-line platinum-containing chemotherapy.
https://t.co/nir5t07bKr
Happy to share our study in CCR showing ⬆️ORR with ICIs in high #TMB tumors, without increased toxicity. Implies favorable risk/ben for single or dual in hTMB. After pembro in TMB>10, excited for ipi/nivo TMB>10 (CheckMate 848)
https://t.co/3LdwWZHLsz
As many have noted, there has been an uptick in confirmed #COVID19 cases in multiple states starting roughly at the beginning of June. There is a major question surrounding how much "re-opening" efforts are contributing to increases in transmission. Figure from @nytimes. 1/10
Today, FDA granted accelerated approval to tazemetostat (TAZVERIK, Epizyme) for relapsed/refractory EZH2 positive follicular lymphoma after 2 prior systemic therapies and for r/r FL with no satisfactory alternative treatment options. #lymsm https://t.co/li1xlsjg4r