FDA approvals and recalls

Oncology: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

23 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Jideytro (zidesamtinib)

    Approved for: JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase in…

    NDA220185

  • Lifyorli (copackaged) (relacorilant)

    Approved for: LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who h…

    NDA220641

  • Hyrnuo (sevabertinib)

    Approved for: HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosi…

    NDA219972

  • Zegfrovy (sunvozertinib)

    Approved for: 1. INDICATIONS AND USAGE ZEGFROVY is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth fac…

    NDA219839

  • Ibtrozi (taletrectinib)

    Approved for: IBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) [see Dosage and Ad…

    NDA219713

  • Avmapki Fakzynja Co-pack (copackaged) (avutometinib potassium and defactinib hydrochloride)

    Approved for: AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic the…

    NDA219616

  • Jobevne (bevacizumab-nwgd)

    Approved for: Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemot…

    BLA761175

  • Romvimza (vimseltinib)

    Approved for: ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functiona…

    NDA219304

  • Ensacove (ensartinib)

    Approved for: ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detect…

    NDA218171

  • Bizengri (zenocutuzumab)

    Approved for: BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harb…

    BLA761352

  • Imdelltra (tarlatamab-dlle)

    Approved for: IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.…

    BLA761344

  • Hercessi (trastuzumab-strf)

    Approved for: Hercessi TM is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. (1.1, 1.2) The treatment of HER2-overexpressing metastat…

    BLA761346

  • Anktiva (nogapendekin alfa inbakicept-pmln)

    Approved for: ANKTIVA, in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). ANKTI…

    BLA761336

  • Lumisight (pegulicianine)

    Approved for: LUMISIGHT is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity followi…

    NDA214511

  • Tevimbra (tislelizumab-jsgr)

    Approved for: TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatme…

    BLA761232

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

9 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

103 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Gynecological Laparoscopic Kit

    Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or endin…

    Z-0183-2027

  • Hysterectomy Kit

    Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or endin…

    Z-0184-2027

  • Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    Reason: Software issue that can cause an increase in spontaneous software closures.

    Z-2951-2026

  • Accelerator, Linear, Medical

    Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

    Z-2406-2026

  • System, Planning, Radiation Therapy Treatment

    Reason: Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not no…

    Z-2646-2026

  • System, Planning, Radiation Therapy Treatment

    Reason: Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not no…

    Z-2647-2026

  • Set, Administration, Intravascular

    Reason: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber…

    Z-3158-2026

  • Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

    Reason: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber…

    Z-3159-2026

  • Pump, Infusion, Implanted, Programmable

    Reason: There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

    Z-2580-2026

  • System, Applicator, Radionuclide, Remote-Controlled

    Reason: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

    Z-2711-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

11 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

298,825 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Fatigue26,366 reports
  2. 2Diarrhoea20,933 reports
  3. 3Nausea18,013 reports
  4. 4Malignant neoplasm progression13,728 reports
  5. 5Asthenia12,515 reports
  6. 6Hot flush11,462 reports
  7. 7Vomiting10,065 reports
  8. 8Myelosuppression9,964 reports
  9. 9Decreased appetite9,563 reports
  10. 10Neutropenia8,747 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

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