FDA Focus

Featured

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

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

Teclera (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