Andrew Merron

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 go.usa.gov/x7URp

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 go.usa.gov/xG4Fn

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. sciencedirect.com/science/articl…

AT 10 years I think we can say our first CAR T patient is cured.

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 ➡️ema.europa.eu/en/news/global…

How does immunotherapy work? Our short video explains how three types of #immunotherapy work against cancer: youtube.com/watch?v=jDdL2b…

Exciting progress in #HCC. 1 approval --> 9 approvals in just 3 years. Hopefully this is just the start...

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 go.usa.gov/xfPXS

FDA approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma #melsm go.usa.gov/xfEu6

Will COVID-19 Permanently Change Cancer Care? nationalacademies.org/news/2020/07/w…

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 ow.ly/p6aH50AAceq

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: collaboration.fda.gov/odac071420 Meeting info & materials: go.usa.gov/xf2dj

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. fda.gov/drugs/guidance…

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. go.usa.gov/xwuay

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) clincancerres.aacrjournals.org/content/early/…

Tune in 6/22, 3:45p to #AACR20 COVID-19 & Cancer: Guidance for Clinical Trial Conduct & Considerations for RWE. Chair: #FDAOncology @harpreet_md. FDA speakers @pkluetz @DrAbernethyFDA & Wendy Rubinstein; @cotahealthcare C.K. Wang & @Syapse @JonathanHirsch abstractsonline.com/pp8/#!/9045/se…

Today 6 PM CET #EHA25Virtual Oral Abstract Session: "Questions and Answers Panel Discussion: #CML Clinical" interesting presentations on: •Asciminib •Mutations in CML •OPTIC Trial •Drugs combinations •#TFR Swedish CML Registry #PatientAdvocacyVirtual #EHATrendingg

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 go.usa.gov/xwyme