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: 05/04/2022
Ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.)

FDA Information
Current as of: 05/04/2022
Abatacept (ORENCIA, Bristol-Myers Squibb Company)

FDA Information
Current as of: 04/19/2023
polatuzumab vedotin-piiq (Polivy, Genentech, Inc.)

FDA Information
Current as of: 04/17/2023
omidubicel-onlv (Omisirge, Gamida Cell Ltd.)

FDA Information
Current as of: 04/03/2023
enfortumab vedotin-ejfv (Padcev, Astellas Pharma)

FDA Information
Current as of: 03/22/2023
retifanlimab-dlwr (Zynyz, Incyte Corporation)

03/22/2023 Pharmacist's Application to Practice: Retifanlimab-dlwr
Bernard Marini

FDA Information
Current as of: 03/16/2023
dabrafenib (Tafinlar, Novartis)

FDA Information
Current as of: 03/03/2023
abemaciclib (Verzenio,, Eli Lilly and Company)

FDA Information
Current as of: 02/09/2023
dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC)

FDA Information
Current as of: 02/03/2023
sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.)

FDA Information
Current as of: 01/27/2023
elacestrant (Orserdu, Stemline Therapeutics, Inc)

01/27/2023 Pharmacist’s Application to Practice: Elacestrant
Monica Chintapenta

FDA Information
Current as of: 01/19/2023
tucatinib (Tukysa, Seagen Inc.)

FDA Information
Current as of: 12/22/2022
mosunetuzumab-axgb (Lunsumio, Genentech, Inc)

12/22/2022 Pharmacist's Application to Practice: Mosunetuzumab
Bernard Marini

FDA Information
Current as of: 12/16/2022
nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals)

12/16/2022 Pharmacist's Application to Practice: Nadofaragene firadenovec-vncg
Kelli Rourke

FDA Information
Current as of: 12/14/2022
capecitabine (Xeloda, Genentech, Inc.)

FDA Information
Current as of: 12/12/2022
adagrasib (Krazati, Mirati Therapeutics, Inc)

12/22/2022 Pharmacist Application to Practice: Adagrasib

FDA Information
Current as of: 12/09/2022
atezolizumab (Tecentriq, Genentech, Inc)

FDA Information
Current as of: 12/01/2022
olutasidenib (Rezlidhia, Forma Therapeutics, Inc.)

12/01/2022 Pharmacist's Application to Practice: Olutasidenib
Bernard Marini

FDA Information
Current as of: 11/18/2022
asparaginase erwinia chrysanthemi (recombinant) (Rylaze, Jazz Pharmaceuticals)

FDA Information
Current as of: 11/10/2022
tremelimumab (Imjudo, AstraZeneca Pharmaceuticals)

11/10/2022 Pharmacist's Application to Practice: Tremelimumab
Rachel Vaught

FDA Information
Current as of: 11/10/2022
brentuximab vedotin (Adcetris, Seagen, Inc)

FDA Information
Current as of: 11/08/2022
cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc)

FDA Information
Current as of: 05/19/2023
epcoritamab-bysp (EPKINLY, Genmab US, Inc.)

05/19/2023 Pharmacist's Application to Practice: Epcoritamab-bysp
Shaniya Pleasant

FDA Information
Current as of: 05/31/2023
olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP)

FDA Information
Current as of: 06/15/2023
glofitamab-gxbm (COLUMVI, Genentech, Inc.)

11/06/2023 Pharmacist's Application to Practice: Glofitamab
Morgan Bizzell

FDA Information
Current as of: 07/31/2023
dostarlimab-gxly (JEMPERLI, GlaxoSmithKline)

FDA Information
Current as of: 08/02/2023
trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.)

FDA Information
Current as of: 07/20/2023
quizartinib (VANFLYTA, Daiichi Sankyo, Inc.)

11/06/2023 Pharmacist's Application to Practice: Quizartinib
Eugene Lee

FDA Information
Current as of: 10/11/2023
Encorafenib (BRAFTOVI, Array BioPharma Inc.)

FDA Information
Current as of: 01/26/2023
pembrolizumab as adjuvant treatment for non-small cell lung cancer (Keytruda, Merck)

FDA Information
Current as of: 01/19/2023
zanubrutinib for CLL or SLL (Brukinsa, BeiGene USA, Inc.)

FDA Information
Current as of: 08/09/2023
pralsetinib (GAVRETO, Genentech, Inc.)

FDA Information
Current as of: 08/11/2023
niraparib and abiraterone acetate (AKEEGA, Janssen Biotech, Inc.)

11/12/2023 Pharmacist’s Application to Practice: Niraparib and Abiraterone Acetate (Akeega™)
Mallori Anderson

FDA Information
Current as of: 09/14/2023
elranatamab-bcmm (ELREXFIO, Pfizer, Inc.)

11/06/2023 Pharmacist's Application to Practice: Elranatamab-bcmm

FDA Information
Current as of: 09/14/2023
melphalan (HEPZATO, Delcath Systems, Inc.)

01/11/2024 Pharmacist’s Application to Practice: Hepzato Kit™
Lainey Vargo

FDA Information
Current as of: 09/14/2023
temozolomide (TEMODAR, Merk)

FDA Information
Current as of: 06/20/2023
talazoparib (TALZENNA, Pfizer, Inc.)

FDA Information
Current as of: 11/10/2022
Tremelimumab (IMJUDO, AztraZeneca)

FDA Information
Current as of: 10/24/2022
Tremelimumab (IMJUDO, AztraZeneca)

FDA Information
Current as of: 08/09/2023
talquetamab-tgvs (TALVEY, Janssen Biotech, Inc.)

08/09/2023 Pharmacist’s Application to Practice: Talquetamab-tgvs
Marguerite Courtney

FDA Information
Current as of: 09/30/2022
futibatinib (Lytgobi, Taiho Oncology, Inc.)

09/30/2022 Pharmacist's Application to Practice: Futibatinib
Mei Ka Fong

FDA Information
Current as of: 11/14/2022
mirvetuximab - soravtansine-gynx (Elahere, ImmunoGen, Inc.)

11/14/2022 Pharmacist’s Application to Practice: Mirvetuximab soravtansine-gynx
Shrina Patel

FDA Information
Current as of: 10/25/2022
teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.)

10/25/2022 Pharmacist’s Application to Practice: Teclistamab-cqyv
Gavyn Walsh

FDA Information
Current as of: 09/26/2023
bosutinib (BOSULIF, Pfizer, Inc.)

FDA Information
Current as of: 10/20/2023
entrectinib (Rozlytrek, Genentech Inc.)

FDA Information
Current as of: 10/24/2023
ivosidenib (Tibsovo, Servier Pharmaceuticals LLC)

FDA Information
Current as of: 10/27/2023
toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.)

FDA Information
Current as of: 11/16/2023
pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma (Keytruda, Merck)

FDA Information
Current as of: 11/16/2023
capivasertib (Truqap, AstraZeneca Pharmaceuticals)

11/26/2023 Pharmacist's Application to Practice: Capivasertib
Rachel Allen

FDA Information
Current as of: 11/16/2023
enzalutamide (Xtandi, Astellas Pharma US, Inc.)

FDA Information
Current as of: 11/27/2023
nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.)

12/27/2023 Pharmacist’s Application to Practice: Nirogacestat (Ogsiveo)
Brooke Lochridge

FDA Information
Current as of: 10/16/2023
pembrolizumab for resectable non-small cell lung cancer (Keytruda, Merck)

FDA Information
Current as of: 11/07/2023
pembrolizumab’s gastric cancer indication has been amended (Keytruda, Merck)

FDA Information
Current as of: 10/31/2023
pembrolizumab with chemotherapy for biliary tract cancer (Keytruda, Merck)

FDA Information
Current as of: 11/08/2023
fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.)

12/08/2023 Pharmacist's Application to Practice: Fruquintinib
Hunter Sowell

FDA Information
Current as of: 11/15/2023
repotrectinib (Augtyro, Bristol-Myers Squibb Company))

01/25/2024 Pharmacist’s Application to Practice: Repotrectinib
Christopher Cornett II

FDA Information
Current as of: 12/13/2023
eflornithine (IWILFIN, USWM, LLC)

12/13/2023 Pharmacist’s Application to Practice: Eflornithine for High-Risk Neuroblastoma
Taylor Gullickson

FDA Information
Current as of: 12/14/2023
belzutifan (Welireg, Merck & Co., Inc.)

FDA Information
Current as of: 12/01/2023
pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma (Jaypirca, Eli Lilly and Company)

FDA Information
Current as of: 01/27/2023
pirtobrutinib for relapsed or refractory mantle cell lymphoma (Jaypirca, Eli Lilly and Company)

01/27/2023 Pharmacist's Application to Practice: Pirtobrutinib
Andy Hawn

FDA Information
Current as of: 12/15/2023
enfortumab vedotin-ejfv in combination with pembrolizumab for metastatic urothelial cancer (Padcev, Astellas Pharma)

FDA Information
Current as of: 01/12/2024
pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer (Keytruda, Merk)

FDA Information
Current as of: 01/18/2024
erdafitinib (Balversa, Janssen Biotech)

FDA Information
Current as of: 02/13/2024
irinotecan liposome (Onivyde, Ipsen)

FDA Information
Current as of: 02/15/2024
tepotinib (Tepmetko, EMD Serono)

FDA Information
Current as of: 02/16/2024
lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.)

FDA Information
Current as of: 02/16/2024
osimertinib (Tagrisso, AstraZeneca)

FDA Information
Current as of: 03/01/2024
amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.)

FDA Information
Current as of: 03/06/2024
inotuzumab ozogamicin (Besponsa, Pfizer)

FDA Information
Current as of: 03/06/2024
nivolumab (Opdivo, Bristol-Myers Squibb Company)

FDA Information
Current as of: 03/07/2024
zanubrutinib with obinutuzumab for relapsed or refractory follicular lymphoma (Brukinsa, BeiGene USA, Inc.)

FDA Information
Current as of: 03/19/2024
ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.)

FDA Information
Current as of: 04/05/2024
fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.)

FDA Information
Current as of: 04/18/2024
alectinib (Alecensa, Genentech, Inc.)

FDA Information
Current as of: 04/22/2024
nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC)

08/27/2024 Pharmacist's Application to Practice: Nogapendekin alfa inbakicept-pmln

FDA Information
Current as of: 04/23/2024
lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company)

FDA Information
Current as of: 04/23/2024
tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.)

FDA Information
Current as of: 04/29/2024
tisotumab vedotin-tftv (Tivdak, Seagen Inc. now a part of Pfizer Inc.)

FDA Information
Current as of: 05/16/2024
tarlatamab-dlle (IMDELLTRA, Amgen. Inc.)

FDA Information
Current as of: 05/30/2024
lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma (Breyanzi, Juno Therapeutics, Inc.)

FDA Information
Current as of: 07/30/2024
aratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC)

FDA Information
Current as of: 05/15/2024
lisocabtagene maraleucel for follicular lymphoma (Breyanzi, Juno Therapeutics, Inc.)

FDA Information
Current as of: 06/06/2024
imetelstat (Rytelo, Geron Corporation)

FDA Information
Current as of: 06/12/2024
selpercatinib for RET fusion-positive thyroid cancer (Retevmo, Eli Lilly and Company)

FDA Information
Current as of: 05/29/2024
selpercatinib for pediatric patients with RET-altered metastatic thyroid cancer (Retevmo, Eli Lilly and Company)

FDA Information
Current as of: 06/14/2024
durvalumab with chemotherapy for endometrial cancer (Imfinzi, AstraZeneca UK Limited)

FDA Information
Current as of: 06/14/2024
blinatumomab (Blincyto, Amgen Inc)

FDA Information
Current as of: 06/17/2024
pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma (Keytruda, Merck)

FDA Information
Current as of: 06/21/2024
adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer (Krazati, Mirati Therapeutics, Inc.)

FDA Information
Current as of: 06/13/2024
repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors (Augtyro, Bristol-Myers Squibb Company)

FDA Information
Current as of: 08/01/2024
dostarlimab-gxly with carboplatin and paclitaxel (Jemperli, GSK)

FDA Information
Current as of: 08/02/2024
afamitresgene autoleucel (TECELRA, Adaptimmune, LLC)

FDA Information
Current as of: 08/02/2024
vorasidenib (Voranigo, Servier Pharmaceuticals LLC)

FDA Information
Current as of: 08/14/2024
axatilimab-csfr (Niktimvo, Incyte Corporation)

FDA Information
Current as of: 08/15/2024
durvalumab for resectable non-small cell lung cancer (Imfinzi, AstraZeneca)

FDA Information
Current as of: 06/26/2024
epcoritamab-bysp for relapsed or refractory follicular lymphoma (Epkinly, Genmab US, Inc.)

FDA Information
Current as of: 08/19/2024
lazertinib with amivantamab-vmjw (Lazcluze, Janssen Biotech, Inc.)

FDA Information
Current as of: 09/12/2024
atezolizumab and hyaluronidase-tqjs (TECENTRIQ HYBREZA, Genentech, Inc.)

FDA Information
Current as of: 09/17/2024
pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma (Keytruda, Merck)

FDA Information

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