Tools: Vol. 41, No. 2

Approved Drugs

• On January 27, 2026, the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) (Janssen Biotech) in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• On February 10, the FDA approved Keytruda® (pembrolizumab) (Merck) as well as Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) (Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.
• On February 19, the FDA approved Calquence® (acalabrutinib) (AstraZeneca) tablets and capsules in combination with Venclexta (venetoclax) (AbbVie and Genentech) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.
• On February 24, the FDA granted traditional approval to Braftovi® (encorafenib) (Array BioPharma) in combination with Erbitux® (cetuximab) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test.
• On February 26, the FDA granted accelerated approval to Hernexeos (zongertinib) (Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung (NSCLC) cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

Drugs in the News

• The FDA granted orphan drug designation to CK0804 (Cellenkos), for the treatment of myelofibrosis.
• The FDA and granted orphan drug designation to CPI-008 (cRGD-ZW800-1) (Curadel Pharma), an integrin-targeted, zwitterionic imaging drug, for margin detection of pancreatic cancer during surgery.
• The FDA granted orphan drug designation to ARB1002 (Arbele), an investigational antibody drug conjugate, for the treatment of pancreatic cancer.
• The FDA granted fast track designation to ETX-19477 (858 Therapeutics), a PARG inhibitor, for the treatment of adult patients with BRCA-mutated, platinum-resistant, high-grade serous ovarian cancer.
• The FDA granted breakthrough therapy designation to zoldonrasib (Revolution Medicines), a RAS(ON) G12D-selective inhibitor, for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.
• The FDA granted fast track designation to Enolen® (Alessa Therapeutics) for the treatment of low to intermediate risk, localized prostate cancer.
• The FDA granted fast track designation to LBL-024 (opamtistomig) (Nanjing Leads Biolabs), a PD-L1/4-1BB bispecific antibody, for the treatment of extrapulmonary neuroendocrine carcinoma.
• The FDA granted breakthrough therapy designation to IPN60340 (Ipsen), an investigational monoclonal antibody targeting BTN3A, in combination with venetoclax and azacitidine (Ven-Aza) for acute myeloid leukemia that is unfit for first line treatment.
• The FDA granted orphan drug designation to gotistobart (BioNTech and OncoC4), a tumor microenvironment-selective regulatory T-cell depletion candidate targeting CTLA-4, for the treatment of squamous NSCLC.
• The FDA granted orphan drug designation to NP-G2-044 (Novita Pharmaceuticals), an investigational small-molecule fascin inhibitor, for the treatment of pancreatic cancer.
• The FDA granted regenerative medicine advanced therapy designation to ECT204 (Eureka Therapeutics), a GPC3-targeting ARTEMIS® CAR T-cell therapy, for the treatment of patients with advanced hepatocellular carcinoma.
• The FDA granted orphan drug designation to LP-284 (Lantern Pharma) for the treatment of soft tissue sarcomas.
• The FDA granted breakthrough therapy designation to sofetabart mipitecan (LY4170156) (Lilly), a novel folate receptor alpha antibody-drug conjugate, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible.
• The FDA granted fast track designation to BNT113 (BioNTech), an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive head and neck squamous cell carcinoma expressing PD-L1.
• The FDA granted breakthrough therapy designation to WU-CART-007 (Soficabtagene Geleucel “Sofi-cel”) (Wugen), an allogenic CAR T-cell therapy, for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
• The FDA granted orphan drug designation to zavabresib (OPN-2853) (Opna Bio), a bromodomain and extra-terminal motif small molecule inhibitor, for the treatment of myelofibrosis.
• The FDA granted breakthrough therapy designation to bezuclastinib (Cogent Biosciences) in combination with sunitinib for patients with gastrointestinal stromal tumors who have received prior treatment with imatinib.
• The FDA granted fast track designation to IBI3003 (Innovent Biologics), an anti-GPRC5D/BCMA/CD3 tri-specific antibody, for the treatment of relapsed or refractory multiple myeloma in patients who have received 4 or more lines of previous anti-myeloma therapies that include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
• The FDA granted orphan drug designation to CTD402 (Imviva Biotech), an investigational allogeneic anti-CD7 CAR T-cell therapy, for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.
• The FDA granted fast track designation to LBL-034 (Nanjing Leads Biolabs), a GPRC5D/ CD3 bispecific antibody, for the treatment of relapsed/refractory multiple myeloma.
• The FDA granted fast track designation to QTX-2101 (Quetzal Therapeutics), an investigational oral arsenic trioxide capsule, for the treatment of patients with acute promyelocytic leukemia.
• The FDA granted orphan drug designation to IFx-2.0 (TuHURA) for the treatment of stage IIB to stage IV cutaneous melanoma.
• The FDA accepted and granted priority review to AstraZeneca and Daiichi Sankyo’s supplemental biologics license application for Datroway (datopotamab deruxtecan) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
• The FDA granted breakthrough therapy designation to zovegalisib (RLY-2608) (Relay Therapeutics) in combination with fulvestrant for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
• The FDA granted fast track designation to pelareorep (Oncolytics Biotech®) in combination with Avastin® (bevacizumab) and leucovorin, fluorouracil, irinotecan for the treatment of patients with KRAS-mutant, microsatellite-stable metastatic colorectal cancer in the second-line setting.
• The FDA granted orphan drug designation to zenocutuzumab-zbco (Partner Therapeutics) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma.
• The FDA granted regenerative medicine advanced therapy designation to KB707 (Krystal Biotech), a redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment, for the treatment of advanced or metastatic non-small cell lung cancer.
• The FDA granted fast track designation to irpagratinib (ABSK-011) (Abbisko Therapeutics), a highly selective small-molecule FGFR4 inhibitor, for the treatment of patients with hepatocellular carcinoma with FGF19 overexpression who have been previously treated with immune checkpoint inhibitors and multi-targeted kinase inhibitors therapies.
• The FDA granted orphan drug designation to HCB101 (HanchorBio), a CD47–SIRPα pathway inhibitor, for the treatment of gastric cancer.
• The FDA granted breakthrough therapy designation to Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) (Johnson & Johnson) as a monotherapy for the treatment of adults with head and neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
• The FDA granted fast track designation to PLT012 (Pilatus Biosciences), an anti-CD36 monoclonal antibody, for the treatment of hepatocellular carcinoma.
• The FDA granted fast track designation to ART6043 (Artios Pharma Limited), a DNA polymerase theta inhibitor, in combination with olaparib, a PARP inhibitor, for the treatment of adult patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.
• The FDA granted orphan drug designation to nesuparib (Onconic Therapeutics), a dual targeting synthetic lethal anticancer candidate, for the treatment of small cell lung cancer.
• The FDA granted fast track designation to SRN-101 (Siren Biotechnology), an AAV-based immuno-gene therapy, for recurrent high-grade glioma.
• The FDA granted fast track designation to AKY-1189 (Aktis Oncology) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have progressed on or after prior systemic therapies.

Devices and Assays

• The FDA approved Optune Pax® (Novocure), a wearable medical device that delivers tumor treating fields, for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.