June 2026 Brief

FDA fast-tracks oral SERD giredestrant for early ER+/HER2- breast cancer after phase 3 shows 30% fewer invasive recurrences.

FDA approves Cavhanza, a nilotinib orally disintegrating tablet for adult Ph+ CML, enabling use with PPIs/H2RAs and meals for easier dosing.

The FDA approved Lupin and Natco’s generic eribulin mesylate for pretreated metastatic breast cancer and unresectable or metastatic liposarcoma.

FDA clears automated PD-L1 22C3 testing on Dako Omnis for 4 more tumors, streamlining labs and guiding Keytruda therapy decisions.

FDA fast-tracks TER-2013, an oral AKT1-selective inhibitor, for HR+/HER2– advanced breast cancer with AKT/PI3K/PTEN alterations.

FDA fast-tracks VS-7375, an oral KRAS G12D inhibitor, opening new hope for pretreated advanced NSCLC and fueling pivotal trials.

FDA clears US enrollment for ateganosine plus cemiplimab in third-line NSCLC, testing telomere-targeting therapy after checkpoint and chemo failure.

A first-in-human trial of the antibody-drug conjugate is planned for later this year.

Off-the-shelf CD19 CAR T azer-cel earns FDA Fast Track after early trials show striking responses in refractory CLL/SLL and marginal zone lymphoma.

The new designation, which adds to an existing orphan drug designation for the same indication, allows for a priority review voucher and other development incentives.

FDA granted RMAT designation to lasme-cel, a CD22-targeting allogeneic CAR-T, for R/R B-ALL, the first such therapy in a pivotal trial for this indication.

Alembic receives tentative FDA approval for generic larotrectinib capsules, a TRK inhibitor for NTRK fusion–positive solid tumors, with potential 180-day exclusivity.

The supplemental biologics license application is supported by the phase 3 ATOMIC trial.

The adjuvant approval of the belzutifan combination is supported by the LITESPARK-022 trial.

The FDA concurrently cleared the VENTANA PTEN (SP218) RxDx assay as a companion diagnostic to identify eligible patients.

Topline data show no overall survival advantage for lurbinectedin monotherapy or combination therapy over investigators' choice in second-line metastatic small cell lung cancer; drug's first-line maintenance approval remains intact.

The FDA set a target date of April 14, 2027 to review ozekibart as targeted treatment for chondrosarcoma.

A phase 3 trial of givastomig is expected to begin as early as the fourth quarter of 2026.

Ofirnoflast is a first-in-class oral allosteric modulator of NEK7 that previously received FDA orphan drug designation.

FDA reviews chemo-free mosunetuzumab plus polatuzumab for relapsed/refractory LBCL, promising outpatient second-line care and longer PFS.

Results from the SPEARHEAD-1 trial supported FDA approval of the engineered T-cell product for patients as young as 12 years of age.

It was previously shown that the STELLAR-303 trial achieved the coprimary end point of OS in the ITT population.

FDA approves palbociclib plus trastuzumab, with/without pertuzumab, and endocrine therapy as maintenance for HR+, HER2+ advanced breast cancer.

FDA approves sacituzumab govitecan-hziy alone or with pembrolizumab as first-line therapy for unresectable/metastatic triple-negative breast cancer.

Tentative approval was given for multiple dose levels of generic enzalutamide tablets for prostate cancer, including 120-mg and 160-mg doses.

FDA clears BESREMi Pen, adding a simpler self-injection choice for adults with polycythemia vera on long-term ropeginterferon therapy.

After 2 prior CRLs, the FDA accepted a resubmitted BLA as a complete class 1 response with a goal date of August 2, 2026 for the oncolytic therapy for melanoma.

FDA issues CRL for Ga-68 edotreotide NET PET kit, citing third-party manufacturing; decentralized SSTR imaging promise remains pending.

The T-cell immunotherapy Orca-T has gained FDA approval in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS).