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Just published: FDA Approval Summary: Pralsetinib for the treatment of #lung and #thyroid cancers with RET gene mutations or fusions. First author Janice Kim @jankim1222, last author Harpreet Singh Harpreet Singh, MD via Clinical Cancer Research #lcsm #thyroidcancer clincancerres.aacrjournals.org/content/early/…

Today, FDA approved the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. go.usa.gov/x6CVW

Read more about today's FDA accelerated approval of sotorasib (Lumakras) for patients with KRAS G12C‑mutated locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy. Drug label 👉 bit.ly/3ftnXO1 #OCENewsBurst 👇 bit.ly/3i84S5I

FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement #OCENewsBurst bit.ly/3yOjvRA

New publication via Clinical Cancer Research : FDA Approval Summary: Pembrolizumab for the treatment of tumor mutational burden-high solid tumors. First author: Dr. Leigh Marcus; last author, Dr. Steven Lemery. Dr Lola Fashoyin-Aje Julia Beaver Rick Pazdur #TMB clincancerres.aacrjournals.org/content/early/…

Final guidance on inclusion of premenopausal women in breast cancer clinical trials is published - fantastic collaborating with so many FDA Oncology and U.S. FDA colleagues on this important issue! Julia Beaver Laleh Amiri-Kordestani, MD #bcsm

Today, U.S. FDA issued a new draft guidance encouraging the inclusion of patients with incurable cancers in clinical trials, regardless of whether they received alternative treatment options. go.usa.gov/x6pzq.

To our new #Strongcope interns: Welcome to the The Osler Medical Residency family!! You all are AMAZING. Can’t wait to see you grow into the physician leaders we all know you will become #OslerPride Alex Horne … Also, that selfie… #nailedit.

The Division of Oncology 1, FDA Office of Oncologic Diseases, hosted a retreat today at Cabin John Park, Bethesda, MD. It was a beautiful day and fantastic to see everyone in person. Rick Pazdur made it official with the obligatory selfie!

We've put together some great resources to facilitate discussion and transparency around #AcceleratedApproval in #oncology, including an easy to search database. Learn about #OCEProjectConfirm at the links below:

The Wild West of Checkpoint Inhibitor Development - Perspective by OCE's Julia Beaver and Rick Pazdur via NEJM. #cancerdrugdevelopment #FDA #ProjectOrbis nejm.org/doi/full/10.10…

Very proud of this effort in collaboration with several colleagues from FDA Oncology (see list in RT below) reviewing important publications, considerations, and regulatory actions with respect to external control data in oncology: annalsofoncology.org/article/S0923-…

This FDA Approval Summary gives you a look into the minds (or more importantly statistcal analysis) of the FDA breast team that reviewed #MONARCHE. Worth a read! OncoAlert #bcsm cc. Erika Hamilton, MD ascopubs.org/doi/abs/10.120…

New U.S. FDA draft guidance illuminates several exciting applications for #ctDNA in the early disease setting including ctDNA for patient selection ctDNA MRD for patient enrichment ctDNA as a measure of response ctDNA as an early endpoint in #clinicaltrials trib.al/mMlpWz9

Our FDA Oncology approval summary for belzutifan, a first-in-class HIF inhibitor which is the first drug approved for early treatment of von Hippel-Lindau disease-associated tumors Jaleh Fallah Gautam Mehta, MD Laleh Amiri-Kordestani, MD Julia Beaver pubmed.ncbi.nlm.nih.gov/35727604/

Today, FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, a newly defined subset of HER2-negative breast cancer. This is the first drug approved to treat this subtype. thread 1/3 #bcsm fda.gov/news-events/pr…

Critical Friends of Cancer Research collaborative effort across #Academia #pharma and FDA Oncology on #ctDNA dynamics for response monitoring during #immunotherapy just published in JCO Precision Oncology. Read here: trib.al/e6Fk2Na #CTMoniTR #WhatFriendsDoes #ctDNAFriends #LCSM Johns Hopkins Kimmel Cancer Center

#FDAOncology perspective: The On- and Off-Ramps of Oncology Accelerated Approval - via NEJM by Dr Lola Fashoyin-Aje Gautam Mehta, MD Julia Beaver Rick Pazdur nejm.org/doi/full/10.10…

We are super excited to welcome the Class of 2026 to our program. They are all outstanding individuals who will do really well here Johns Hopkins Kimmel Cancer Center. Congratulations! #1Fellowship1Family

The #cancer treatment landscape has changed dramatically since 2000. This Review summarizes trends in the approval of oncology #therapeutic products by #FDA from 2000 to 2022, based on their mechanism of action & primary target. A must read. nature.com/articles/s4157…