FDA Focus

Stay current on the FDA's new approvals and expanded indications in the oncology field. For select new agents, you'll also find video commentary from a clinical pharmacist expert, sharing their perspective on how the news affects the treatment landscape and what the advanced practitioner needs to know.

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Datroway (datopotamab deruxtecan-dlnk) for unresectable or metastatic, HR-positive, HER2-negative breast cancer

Key Clinical Studies:

TROPION-Breast01 (NCT05104866)

Drug Class/Description:

Trop-2-directed antibody and topoisomerase inhibitor conjugate

January 17, 2025

Calquence (acalabrutinib) with bendamustine and rituximab for mantle cell lymphoma

Key Clinical Studies:

ECHO (NCT02972840)

Drug Class/Description:

Kinase inhibitor

January 16, 2025

Lumakras (sotorasib) with Vectibix (panitumumab) for KRAS G12C-mutated colorectal cancer

Key Clinical Studies:

CodeBreaK 300 (NCT05198934)

Drug Class/Description:

Inhibitor of the RAS GTPase family

January 16, 2025

Braftovi (encorafenib) with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Key Clinical Studies:

BREAKWATER (NCT04607421)

Drug Class/Description:

Kinase inhibitor

December 20, 2024

Ensacove (ensartinib) for ALK-positive locally advanced or metastatic non-small cell lung cancer

Key Clinical Studies:

eXALT3 (NCT02767804)

Drug Class/Description:

Kinase inhibitor

December 18, 2024

Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients

Key Clinical Studies:

MSB-GVHD001 (NCT02336230)

Drug Class/Description:

Allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy

December 18, 2024

Unloxcyt (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma

Key Clinical Studies:

Study CK-301-101 (NCT03212404)

Drug Class/Description:

Programmed death ligand-1 (PD-L1) blocking antibody

December 13, 2024

Bizengri (zenocutuzumab-Zbco) for non-small cell lung cancer and pancreatic adenocarcinoma

Key Clinical Studies:

eNRGy study (NCT02912949)

Drug Class/Description:

Bispecific HER2- and HER3-directed antibody

December 4, 2024

Imfinzi (durvalumab) for limited-stage small cell lung cancer

Key Clinical Studies:

ADRIATIC (NCT03703297)

Drug Class/Description:

Programmed death-ligand 1 (PD-L1) blocking antibody

December 4, 2024

Ziihera (zanidatamab-hrii) for previously treated unresectable or metastatic HER2-positive biliary tract cancer

Key Clinical Studies:

HERIZON-BTC-01 (NCT04466891)

Drug Class/Description:

Bispecific HER2-directed antibody

November 20, 2024

Revuforj (revumenib) for relapsed or refractory acute leukemia with a KMT2A translocation

Key Clinical Studies:

SNDX-5613-0700, NCT04065399; AUGMENT-101

Drug Class/Description:

Menin inhibitor

November 15, 2024

Aucatzyl (obecabtagene autoleucel) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Key Clinical Studies:

FELIX (NCT04404660)

Drug Class/Description:

CD19-directed genetically modified autologous T cell immunotherapy

November 8, 2024

Scemblix (asciminib) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase

Key Clinical Studies:

ASC4FIRST (NCT04971226)

Drug Class/Description:

Kinase inhibitor

October 29, 2024

Vyloy (zolbetuximab-clzb) with fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma

Key Clinical Studies:

SPOTLIGHT (NCT03504397); GLOW (NCT03653507)

Drug Class/Description:

Claudin 18.2-directed cytolytic antibody

October 18, 2024

Itovebi (inavolisib) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer

Key Clinical Studies:

INAVO120 (NCT04191499)

Drug Class/Description:

Kinase inhibitor

October 10, 2024

Opdivo (nivolumab) for resectable non-small cell lung cancer

Key Clinical Studies:

CHECKMATE-816 (NCT02998528)

Drug Class/Description:

Programmed death receptor-1 (PD-1)-blocking antibody

October 3, 2024

Retevmo (selpercatinib) for RET-mutant medullary thyroid cancer

Key Clinical Studies:

LIBRETTO-001 (NCT03157128); LIBRETTO-431 (NCT04194944); LIBRETTO-531 (NCT04211337); LIBRETTO-121 (NCT03899792)

Drug Class/Description:

Kinase inhibitor

September 27, 2024

Tagrisso (osimertinib) for locally advanced, unresectable (stage III) non-small cell lung cancer

Key Clinical Studies:

ADAURA (NCT02511106); LAURA trial (NCT03521154); FLAURA (NCT02296125); FLAURA2 (NCT04035486); AURA3 (NCT02151981)

Drug Class/Description:

Kinase inhibitor

September 25, 2024

Sarclisa (isatuximab-irfc) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant

Key Clinical Studies:

ICARIA-MM (NCT0299033); IKEMA (NCT03275285); IMROZ (NCT03319667)

Drug Class/Description:

CD38-directed cytolytic antibody

September 20, 2024

Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer

Key Clinical Studies:

MARIPOSA (NCT04487080); MARIPOSA-2 (NCT04988295); PAPILLON (NCT04538664); CHRYSALIS (NCT02609776)

Drug Class/Description:

Bispecific EGF receptor-directed and MET receptordirected antibody

September 19, 2024

Kisqali (ribociclib) with an aromatase inhibitor for adjuvant treatment of patients with HR-positive, HER2-negative stages II and III early breast cancer at high risk of recurrence

Key Clinical Studies:

NATALEE (NCT03701334); MONALEESA-2 (NCT01958021); MONALEESA-7 (NCT02278120); MONALEESA-3 (NCT06129786); COMPLEEMENT-1 (NCT 02941926)

Drug Class/Description:

Kinase inhibitor

September 17, 2024

Keytruda (pembrolizumab) with pemetrexed and platinum chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

Key Clinical Studies:

KEYNOTE-483 (NCT02784171)

Drug Class/Description:

Programmed death receptor-1 (PD-1)-blocking antibody

September 17, 2024

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for subcutaneous injection for non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma

Key Clinical Studies:

IMscin001 (NCT03735121); IMpower010 (NCT02486718); IMpower110 (NCT02409342); IMpower150 (NCT02366143); IMpower130 (NCT02367781); OAK (NCT02008227); IMpower133 (NCT02763579); IMbrave150 (NCT03434379); IMspire150 (NCT02908672); ML39345 (NCT03141684); IMscin002 (NCT03735121)

Drug Class/Description:

Programmed death-ligand 1 (PD-L1) blocking antibody, and Endoglycosidase

September 12, 2024

Lazcluze (lazertinib) in combination with amivantamab-vmjw for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations

Key Clinical Studies:

MARIPOSA (NCT04487080)

Drug Class/Description:

Kinase inhibitor

August 19, 2024

Imfinzi (durvalumab) for resectable non-small cell lung cancer

Key Clinical Studies:

AEGEAN (NCT03800134); PACIFIC study (NCT02125461); POSEIDON (NCT03164616); CASPIAN (NCT03043872); TOPAZ-1 (NCT03875235); HIMALAYA study (NCT03298451); DUO-E (NCT04269200)

Drug Class/Description:

Programmed death receptor-1 (PD-1)-blocking antibody

August 15, 2024

Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease

Key Clinical Studies:

AGAVE-201 (NCT04710576)

Drug Class/Description:

Colony stimulating factor-1 receptor (CSF-1R)-blocking antibody

August 14, 2024

Voranigo (vorasidenib) for adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Key Clinical Studies:

INDIGO trial (NCT04164901)

Drug Class/Description:

Isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor

August 6, 2024

Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma

Key Clinical Studies:

SPEARHEAD-1 (NCT04044768)

Drug Class/Description:

Melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy

August 2, 2024

Jemperli (dostarlimab-gxly) for primary advanced or recurrent endometrial cancer

Key Clinical Studies:

RUBY (NCT03981796); GARNET (NCT02715284)

Drug Class/Description:

Programmed death receptor-1 (PD-1)-blocking antibody

August 1, 2024

Table of Contents Archive

FDA Focus

Datroway (datopotamab deruxtecan-dlnk) for unresectable or metastatic, HR-positive, HER2-negative breast cancer

Calquence (acalabrutinib) with bendamustine and rituximab for mantle cell lymphoma

Lumakras (sotorasib) with Vectibix (panitumumab) for KRAS G12C-mutated colorectal cancer

Braftovi (encorafenib) with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Ensacove (ensartinib) for ALK-positive locally advanced or metastatic non-small cell lung cancer

Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients

Unloxcyt (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma

Bizengri (zenocutuzumab-Zbco) for non-small cell lung cancer and pancreatic adenocarcinoma

Imfinzi (durvalumab) for limited-stage small cell lung cancer

Ziihera (zanidatamab-hrii) for previously treated unresectable or metastatic HER2-positive biliary tract cancer

Revuforj (revumenib) for relapsed or refractory acute leukemia with a KMT2A translocation

Aucatzyl (obecabtagene autoleucel) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Scemblix (asciminib) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase

Vyloy (zolbetuximab-clzb) with fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma

Itovebi (inavolisib) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer

Opdivo (nivolumab) for resectable non-small cell lung cancer

Retevmo (selpercatinib) for RET-mutant medullary thyroid cancer

Tagrisso (osimertinib) for locally advanced, unresectable (stage III) non-small cell lung cancer

Sarclisa (isatuximab-irfc) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant

Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer

Kisqali (ribociclib) with an aromatase inhibitor for adjuvant treatment of patients with HR-positive, HER2-negative stages II and III early breast cancer at high risk of recurrence

Keytruda (pembrolizumab) with pemetrexed and platinum chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for subcutaneous injection for non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma

Lazcluze (lazertinib) in combination with amivantamab-vmjw for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations

Imfinzi (durvalumab) for resectable non-small cell lung cancer

Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease

Voranigo (vorasidenib) for adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma

Jemperli (dostarlimab-gxly) for primary advanced or recurrent endometrial cancer

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