🔥The 9th Round of Easy Loan, Earn $40 Reward is in progress❗️ ⏰ Promotion Period: January 15th - Feburary 15th, 2025 👉 Register now and check more details at gate.io/campaigns/358

OCE supports efforts to modernize clinical trials and evidence generation. COVID-19 provided proof of concept for several decentralized trial modifications, and OCE is working to evaluate them to potentially deploy in future trials. Learn more: fda.gov/about-fda/onco…

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…

“Today’s approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients," OCE Director Richard Pazdur, MD, said. #CancerMoonshot #EndCancerAsWeKnowIt

Congratulations to Dr. Monica Bertagnolli @bertagnollimm on her nomination as Director of National Cancer Institute! We look forward to continued collaboration with the NCI to advance the development of oncology products for patients with cancer. #CancerMoonshot whitehouse.gov/briefing-room/…

Applications are due August 15 for the 2022-23 FDA-AACR Oncology Educational Fellowship. Selected fellows will learn about oncology drug development and the regulatory review process while participating in mentoring and networking events. Learn more: bit.ly/3zXMkwA

The FDA Oncologic Drugs Advisory Committee (#FDAODAC) is scheduled to meet virtually on Sept. 22-23, 2022. Meeting materials to be posted no later than 2 days prior. Meeting times and topics available here ⬇️ fda.gov/advisory-commi…

The Sept. 22-23, 2022 FDA Oncologic Drugs Advisory Committee (#FDAODAC) meetings will be available to watch on YouTube beginning at 9 am ET both days: September 22, 2022: youtu.be/SON2biqVX_8 September 23, 2022: youtu.be/cjkgIpaxHlI Meeting info: fda.gov/advisory-commi…

FDA granted regular approval to selpercatinib (Retevmo, Eli Lilly) for patients with locally advanced/metastatic non-small cell lung cancer with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. fda.gov/drugs/resource… #OCENewsBurst

#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…

Oncologic Drugs Advisory Committee 4-Yes and 9-No on the question: Do the current benefits of poziotinib outweigh its risks for the treatment of patients with NSCLC with HER2 exon 20 insertion mutations? #FDAODAC Watch: Sept. 22 FDA youtu.be/SON2biqVX_8

Oncologic Drugs AC votes 2-Yes vs 14-No on the question: Given potential detriment in OS, failure to demonstrate a PFS benefit, and lack of an appropriate dose, is the benefit-risk profile of melphalan flufenamide favorable for the currently indicated patient population? #FDAODAC

FDA is seeking applications for the Centers of Excellence in Regulatory Science and Innovation (CERSI) program. Submit letters of intent by 10/31/22 and apply by 12/22/22. #OCESciCollab grants.nih.gov/grants/guide/r…

FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for adults w/folate receptor alpha positive platinum-resistant ovarian, fallopian or primary peritoneal cancer after 1-3 prior systemic treatment regimens. fda.gov/drugs/resource… #OCENewsBurst

Funding for applied regulatory research in oncology is available through the FY23 FDA Broad Agency Announcement. Submission deadline Jan. 23, 2023. Learn more here ⤵️ fda.gov/about-fda/onco… #OCESciCollab

We welcome Dr. Joshua Donaldson to the Div. of Oncology 1 Breast/GYN Team. Hailing from Lumberton, NJ, he earned a Chemistry degree TCNJ, then did MD, PhD & internal med residency Thomas Jefferson University and onc fellowship Johns Hopkins Hematology and Oncology Fellowship. Prior to FDA, he taught @VUMC_MD. #OCECareers

FDA approved elacestrant (Orserdu) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. #OCENewsBrief #bcsm fda.gov/drugs/resource…

Today at 2:30 pm ET #AACR23 join #FDAOncology for this discussion of the approval of fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. abstractsonline.com/pp8/#!/10828/s…

Read an interview with OCE Director Richard Pazdur about causes of oncology drug shortages and what the FDA can and can't do to fix it, via The Cancer Letter open access article.

Open access article in The Cancer Letter worth reading. Discusses FDA Oncology Rick Pazdur's perspective on the oncology #drugshortage

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer. fda.gov/drugs/drug-app… #PCSM #OCENewsBurst