FDA Drug Updates
As a service to our members, HOPA provides information about newly approved or updated oncology drugs. Whether you are early in your oncology pharmacy career, or you have years of experience, knowledge is power. That's why we curate the latest hematology/oncology drug updates with links to their corresponding FDA announcements.
Please note: In providing his information for members, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.
Take a look at the drug listings below. To see the latest entries, sort from Newest to Oldest. For additional insight, look for our member-submitted Pharmacist Applications to Practice or visit our PAP page for a listing of recent PAPs.
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Current as of: 05/04/2022Ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.)
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Current as of: 05/04/2022Abatacept (ORENCIA, Bristol-Myers Squibb Company)
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Current as of: 04/19/2023polatuzumab vedotin-piiq (Polivy, Genentech, Inc.)
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Current as of: 04/17/2023omidubicel-onlv (Omisirge, Gamida Cell Ltd.)
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Current as of: 04/03/2023enfortumab vedotin-ejfv (Padcev, Astellas Pharma)
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Current as of: 03/22/2023retifanlimab-dlwr (Zynyz, Incyte Corporation)
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Current as of: 03/16/2023dabrafenib (Tafinlar, Novartis)
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Current as of: 03/03/2023abemaciclib (Verzenio,, Eli Lilly and Company)
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Current as of: 02/09/2023dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC)
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Current as of: 02/03/2023sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.)
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Current as of: 01/27/2023elacestrant (Orserdu, Stemline Therapeutics, Inc)
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Current as of: 01/19/2023tucatinib (Tukysa, Seagen Inc.)
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Current as of: 12/22/2022mosunetuzumab-axgb (Lunsumio, Genentech, Inc)
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Current as of: 12/16/2022nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals)
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Current as of: 12/14/2022capecitabine (Xeloda, Genentech, Inc.)
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Current as of: 12/12/2022adagrasib (Krazati, Mirati Therapeutics, Inc)
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Current as of: 12/09/2022atezolizumab (Tecentriq, Genentech, Inc)
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Current as of: 12/01/2022olutasidenib (Rezlidhia, Forma Therapeutics, Inc.)
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Current as of: 11/18/2022asparaginase erwinia chrysanthemi (recombinant) (Rylaze, Jazz Pharmaceuticals)
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Current as of: 11/10/2022tremelimumab (Imjudo, AstraZeneca Pharmaceuticals)
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Current as of: 11/10/2022brentuximab vedotin (Adcetris, Seagen, Inc)
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Current as of: 11/08/2022cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc)
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Current as of: 05/19/2023epcoritamab-bysp (EPKINLY, Genmab US, Inc.)
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Current as of: 05/31/2023olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP)
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Current as of: 06/15/2023glofitamab-gxbm (COLUMVI, Genentech, Inc.)
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Current as of: 07/31/2023dostarlimab-gxly (JEMPERLI, GlaxoSmithKline)
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Current as of: 08/02/2023trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.)
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Current as of: 07/20/2023quizartinib (VANFLYTA, Daiichi Sankyo, Inc.)
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Current as of: 10/11/2023Encorafenib (BRAFTOVI, Array BioPharma Inc.)
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Current as of: 01/26/2023pembrolizumab as adjuvant treatment for non-small cell lung cancer (Keytruda, Merck)
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Current as of: 01/19/2023zanubrutinib for CLL or SLL (Brukinsa, BeiGene USA, Inc.)
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Current as of: 08/09/2023pralsetinib (GAVRETO, Genentech, Inc.)
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Current as of: 08/11/2023niraparib and abiraterone acetate (AKEEGA, Janssen Biotech, Inc.)
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Current as of: 09/14/2023elranatamab-bcmm (ELREXFIO, Pfizer, Inc.)
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Current as of: 09/14/2023melphalan (HEPZATO, Delcath Systems, Inc.)
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Current as of: 09/14/2023temozolomide (TEMODAR, Merk)
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Current as of: 06/20/2023talazoparib (TALZENNA, Pfizer, Inc.)
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Current as of: 11/10/2022Tremelimumab (IMJUDO, AztraZeneca)
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Current as of: 10/24/2022Tremelimumab (IMJUDO, AztraZeneca)
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Current as of: 08/09/2023talquetamab-tgvs (TALVEY, Janssen Biotech, Inc.)
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Current as of: 09/30/2022futibatinib (Lytgobi, Taiho Oncology, Inc.)
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Current as of: 11/14/2022mirvetuximab - soravtansine-gynx (Elahere, ImmunoGen, Inc.)
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Current as of: 10/25/2022teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.)
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Current as of: 09/26/2023bosutinib (BOSULIF, Pfizer, Inc.)
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Current as of: 10/20/2023entrectinib (Rozlytrek, Genentech Inc.)
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Current as of: 10/24/2023ivosidenib (Tibsovo, Servier Pharmaceuticals LLC)
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Current as of: 10/27/2023toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.)
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Current as of: 11/16/2023pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma (Keytruda, Merck)
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Current as of: 11/16/2023capivasertib (Truqap, AstraZeneca Pharmaceuticals)
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Current as of: 11/16/2023enzalutamide (Xtandi, Astellas Pharma US, Inc.)
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Current as of: 11/27/2023nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.)
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Current as of: 10/16/2023pembrolizumab for resectable non-small cell lung cancer (Keytruda, Merck)
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Current as of: 11/07/2023pembrolizumab’s gastric cancer indication has been amended (Keytruda, Merck)
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Current as of: 10/31/2023pembrolizumab with chemotherapy for biliary tract cancer (Keytruda, Merck)
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Current as of: 11/08/2023fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.)
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Current as of: 11/15/2023repotrectinib (Augtyro, Bristol-Myers Squibb Company))
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Current as of: 12/13/2023eflornithine (IWILFIN, USWM, LLC)
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Current as of: 12/14/2023belzutifan (Welireg, Merck & Co., Inc.)
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Current as of: 12/01/2023pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma (Jaypirca, Eli Lilly and Company)
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Current as of: 01/27/2023pirtobrutinib for relapsed or refractory mantle cell lymphoma (Jaypirca, Eli Lilly and Company)
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Current as of: 12/15/2023enfortumab vedotin-ejfv in combination with pembrolizumab for metastatic urothelial cancer (Padcev, Astellas Pharma)
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Current as of: 01/12/2024pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer (Keytruda, Merk)
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Current as of: 01/18/2024erdafitinib (Balversa, Janssen Biotech)
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Current as of: 02/13/2024irinotecan liposome (Onivyde, Ipsen)
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Current as of: 02/15/2024tepotinib (Tepmetko, EMD Serono)
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Current as of: 02/16/2024lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.)
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Current as of: 02/16/2024osimertinib (Tagrisso, AstraZeneca)
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Current as of: 03/01/2024amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.)
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Current as of: 03/06/2024inotuzumab ozogamicin (Besponsa, Pfizer)
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Current as of: 03/06/2024nivolumab (Opdivo, Bristol-Myers Squibb Company)
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Current as of: 03/07/2024zanubrutinib with obinutuzumab for relapsed or refractory follicular lymphoma (Brukinsa, BeiGene USA, Inc.)
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Current as of: 03/19/2024ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.)
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Current as of: 04/05/2024fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.)
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Current as of: 04/18/2024alectinib (Alecensa, Genentech, Inc.)
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Current as of: 04/22/2024nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC)
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Current as of: 04/23/2024lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company)
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Current as of: 04/23/2024tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.)
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Current as of: 04/29/2024tisotumab vedotin-tftv (Tivdak, Seagen Inc. now a part of Pfizer Inc.)
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Current as of: 05/16/2024tarlatamab-dlle (IMDELLTRA, Amgen. Inc.)
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Current as of: 05/30/2024lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma (Breyanzi, Juno Therapeutics, Inc.)
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Current as of: 07/30/2024aratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC)
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Current as of: 05/15/2024lisocabtagene maraleucel for follicular lymphoma (Breyanzi, Juno Therapeutics, Inc.)
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Current as of: 06/06/2024imetelstat (Rytelo, Geron Corporation)
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Current as of: 06/12/2024selpercatinib for RET fusion-positive thyroid cancer (Retevmo, Eli Lilly and Company)
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Current as of: 05/29/2024selpercatinib for pediatric patients with RET-altered metastatic thyroid cancer (Retevmo, Eli Lilly and Company)
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Current as of: 06/14/2024durvalumab with chemotherapy for endometrial cancer (Imfinzi, AstraZeneca UK Limited)
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Current as of: 06/14/2024blinatumomab (Blincyto, Amgen Inc)
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Current as of: 06/17/2024pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma (Keytruda, Merck)
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Current as of: 06/21/2024adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer (Krazati, Mirati Therapeutics, Inc.)
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Current as of: 06/13/2024repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors (Augtyro, Bristol-Myers Squibb Company)
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Current as of: 08/01/2024dostarlimab-gxly with carboplatin and paclitaxel (Jemperli, GSK)
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Current as of: 08/02/2024afamitresgene autoleucel (TECELRA, Adaptimmune, LLC)
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Current as of: 08/02/2024vorasidenib (Voranigo, Servier Pharmaceuticals LLC)
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Current as of: 08/14/2024axatilimab-csfr (Niktimvo, Incyte Corporation)
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Current as of: 08/15/2024durvalumab for resectable non-small cell lung cancer (Imfinzi, AstraZeneca)
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Current as of: 06/26/2024epcoritamab-bysp for relapsed or refractory follicular lymphoma (Epkinly, Genmab US, Inc.)
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Current as of: 08/19/2024lazertinib with amivantamab-vmjw (Lazcluze, Janssen Biotech, Inc.)
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Current as of: 09/12/2024atezolizumab and hyaluronidase-tqjs (TECENTRIQ HYBREZA, Genentech, Inc.)
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Current as of: 09/17/2024pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma (Keytruda, Merck)
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Current as of: 09/17/2024Ribociclib with an aromatase inhibitor (Kisqali, Novartis Pharmaceuticals Corporation)
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Current as of: 09/20/2024Isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone (Sarclisa, Sanofi-Aventis U.S. LLC)
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Current as of: 09/19/2024Amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (Rybrevant, Janssen Biotech, Inc.)
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Current as of: 09/25/2024Osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy (Tagrisso, AstraZeneca Pharmaceuticals)
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Current as of: 09/27/2024Selpercatinib for medullary thyroid cancer with a RET mutation (Retevmo, Eli Lilly and Company)
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Current as of: 10/03/2024Nivolumab for resectable non-small cell lung cancer (Opdivo, Bristol Myers Squibb Company)
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Current as of: 10/10/2024Inavolisib with palbociclib and fulvestrant (Itovebi, Genentech, Inc.)
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Current as of: 10/18/2024Zolbetuximab-clzb with chemotherapy (Vyloy, Astellas Pharma US, Inc.)
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Current as of: 10/29/2024Asciminib (Scemblix, Novartis AG)
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Current as of: 11/08/2024Obecabtagene autoleucel (Aucatzyl, Autolus Inc.)
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Current as of: 11/15/2024Revumenib (Revuforj, Syndax Pharmaceuticals, Inc.)
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Current as of: 11/20/2024Zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.)
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Current as of: 12/04/2024Zenocutuzumab-zbco (Bizengri, Merus N.V.)
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Current as of: 12/04/2024Durvalumab for limited-stage small cell lung cancer (Imfinzi, AstraZeneca)