This article was updated on June 23, 2026.
In May, the US Food and Drug Administration (FDA) approved 10 treatments for a range of cancers, including vepdegestrant (Veppanu), ruxolitinib (Jakafi XR), zenocutuzumab-zbco (Bizengri), sonrotoclax (Beqalzi), decitabine and cedazuridine (Inqovi), atezolizumab (Tecentriq), fam-trastuzumab deruxtecan-nxki (Enhertu), datopotamab deruxtecan-dlnk (Datroway), pivekimab sunirine-pvzy (Decnupaz), and durvalumab (Imfinzi).
Veppanu (vepdegestrant)
On May 1, the FDA approved Veppanu for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least 1 line of endocrine therapy.1
Veppanu is a heterobifunctional protein degrader. The recommended dose is 200 mg taken orally once daily with food until disease progression or unacceptable toxicity.
Veppanu has no boxed warning but does have warnings for QTc interval prolongation and embryo-fetal toxicity. There are no contraindications for Veppanu.
Jakafi XR (ruxolitinib)
On May 1, the FDA approved Jakafi XR (ruxolitinib) for the treatment of adults with intermediate or high-risk myelofibrosis; adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host-disease (GVHD) or chronic GVHD after failure of 1 or 2 lines of systemic therapy.2
Jakafi XR is a kinase inhibitor. The recommended dose for patients with myelofibrosis is based on the patient’s baseline platelet count; for platelet counts greater than 200 × 109/L, the recommended dose is a 44 mg tablet orally once daily; for patients with platelet counts 100 × 109/L to 200 × 109/L, a 33 mg tablet once daily; for patients with platelet counts 50 × 109/L to less than 100 × 109/L, 11 mg once daily. For patients with PV, the recommended starting dose is 22 mg given orally once daily; for GVHD it is 11 mg once daily, and for chronic GVHD it is 22 mg once daily.
Jakafi XR has no boxed warning but has warnings for thrombocytopenia, anemia, and neuropenia; infection; symptom exacerbation following treatment interruption and discontinuation; non-melanoma skin cancer; lipid elevation; major adverse cardiovascular events; thrombosis; and the development of secondary malignancies. There are no contraindications for Jakafi XR.
Bizengri (zenocutuzumab-zbco)
On May 8, the FDA approved Bizengri for the treatment of adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy.3
Bizengri is a bispecific HER2- and HER3-directed antibody with a recommended dose of 750 mg as an intravenous infusion every 2 weeks until disease progression or unacceptable toxicity.
Bizengri has a boxed warning for embryo-fetal toxicity. Advise patients of this risk and assess the need for effective contraception. Bizengri also has warnings for infusion-related reactions (IRR)/hypersensitivity/anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction. There are no contraindications for Bizengri.
Beqalzi (sonrotoclax)
On May 13, the FDA approved Beqalzi for adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.4
Bequalzi is a BCL2 inhibitor. Following a 4-week ramp-up phase to reduce the risk of tumor lysis syndrome, the recommended dose is 320 mg taken orally once daily until disease progression or unacceptable toxicity. Tablets should be taken with food and water.
Beqalzi has no boxed warning but has warnings for tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity. Beqalzi is contraindicated for concomitant use with strong CYP3A inhibitors at initiation and during the ramp-up phase.
Inqovi (decitabine and cedazuridine)
On May 13, the FDA approved Inqovi in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia in adults aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.5
Inqovi is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor. It has a recommended dose of 1 tablet (35 mg decitabine and 100 mg cedazuridine) orally once daily on days 1 through 5 of each 28-day cycle. Inqovi should be taken on an empty stomach.
Inqovi has no boxed warning but has warnings for myelosuppression and embryo-fetal toxicity. There are no contraindications for Inqovi.
Tecentriq (ateolizumab)
On May 15, the FDA approved Tecentriq and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as adjuvant treatments for adults with muscle-invasive bladder cancer after cystectomy who have had circulating tumor DNA molecular residual disease as determined by an FDA-authorized test.6
Tecentriq is a PD-L1 blocking antibody. After cystectomy, the recommended dose is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year.
Tecentriq Hybreza is a combination of a PD-L1 blocking antibody and an endoglycosidase. The recommended dose by injection is 1875 mg atezolizumab and 30,000 units hyaluronidase per 15 mL (125 mg/2000 units per mL) solution in a single-dose vial, given after cystectomy every 3 weeks for up to a year.
Tecentriq and Tecentriq Hybreza have no boxed warning but have warnings for immune-mediated adverse reactions, infusion-related reactions, embryo-fetal toxicity, and complications of allogeneic haematopoietic stem cell transplantation (HSCT). Tecentriq Hybreza is contraindicated in patients with known hypersensitivity to hyaluronidase or any of its excipients.
Enhertu (fam-trastuzumab deruxtecan-nxki)
On May 15, the FDA approved Enhertu (T-DXd) for 2 separate indications in adults with HER2-positive early-stage breast cancer.7 The first is for T-DXd followed by taxane, trastuzumab, and pertuzumab (THP) for the neoadjuvant treatment of adults with HER2-positive stage II or III breast cancer, as determined by an FDA-approved test. The second is for T-DXd for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. It has a recommended neoadjuvant dose of 5.4 mg/kg every 3 weeks for 4 cycles, followed by the THP regimen for 4 cycles. The recommended dose for post-neoadjuvant treatment is 5.4 mg/kg every 3 weeks for 14 cycles or until disease recurrence or unacceptable toxicity.
Enhertu has boxed warnings for ILD and embryo-fetal toxicity. Signs and symptoms for ILD/pneumonitis include cough, dyspnea, fever, and new or worsening respiratory symptoms. Permanently discontinue use in patients with grade 2 or higher ILD/pneumonitis. Advise patients of potential fetal harm and assess the need for effective contraception. Additional warnings include neutropenia and left ventricular dysfunction. There are no contraindications for Enhertu.
Datroway (datopotamab deruxtecan-dlnk)
On May 22, the FDA approved Datroway for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.8
Datroway is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. The recommended dose is 6 mg/kg administered as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.
Datroway has no boxed warning but has warnings for ILD/pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity. There are no contraindications for Datroway.
Decnupaz (pivekimab sunirine-pvzy)
On May 27, the FDA approved Decnupaz for the treatment of adults with blastic plasmacyoid dendritic cell neoplasm.9
Decnupaz is a CD123-directed antibody and alkylating agent conjugate. The recommended dose is 0.045 mg/kg once every 3 weeks until disease progression or unacceptable toxicity.
Decnupaz has a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease. Closely monitor liver test and total bilirubin before each dose of Decnupaz. Decnupaz has additional warnings for IRR, edema, sulfite allergic reactions, and embryo-fetal toxicity. There are no contraindications for Decnupaz.
Imfinzi (durvalumab)
On May 28, the FDA approved Imfinzi in combination with Bacillus Calmette-Guerin (BCG) for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer.10
Imfinzi is a PD-L1 blocking antibody. For patients with a body weight of 30 kg or more, the recommended dose is 1500 mg every 4 weeks for 13 cycles in combination with BCG induction and maintenance treatment. For patients who weigh less than 30 kg, the recommended dose is 20 mg/kg every 4 weeks for 13 cycles in combination with BCG induction and maintenance.
Imfinzi has no boxed warning but does have warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity. There are no contraindications for Imfinzi.
Package Insert. Arvinas Operations, Inc. 2026. Accessed June 3, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219835Orig1s000lbl.pdf Package Insert. Incyte. 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217180Orig1s000lbl.pdf Package Insert. Merus N.V.. 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761352s010lbl.pdf Package Insert. BeOne Medicines. 2026. Accessed June 3, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220711Orig1s000lbl.pdf Package Insert. Taiho Oncology. 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/0212576s008lbl.pdf Package Insert. Genentech Inc. 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761347s008lbl.pdf Package Insert. Daiichi Sankyo. 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761139s041s043lbl.pdf Package Insert. Daiichi Sankyo. 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761394s003lbl.pdf Package Insert. Abbvie Inc. 2026. Accessed June 3, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761460Orig1s000lbl.pdf Package Insert. AstraZeneca. 2026. Accessed June 4, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761069s053lbl.pdf March
FDA Roundup: March 2026
In March, the US Food and Drug Administration (FDA) approved 3 treatments for a range of cancers, including teclistamab (Tecvayli), nivolumab (Opdivo), and relacorilant (Lifyorli).
Tecvayli (teclistamab)
On March 5, the FDA approved Tecvayli in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.1
Tecvayli is a bispecific B-cell maturation antigen-directed CD3 T-cell engager. When in combination with daratumumab hyaluronidase-fihj, step-up doses of 0.06 mg/kg on day 1 and 0.3 mg/kg on day 3 should be administered, followed by 1.5 mg/kg once a week for weeks 2 through 8. On weeks 9 to 24, administer 3 mg/kg every 2 weeks, then every 4 weeks starting on week 25 until disease progression or unacceptable toxicity. One day before starting Tecvayli, administer subcutaneous daratumumab hyaluronidase-fihj 1800 mg/30,000 units. Continue once weekly for weeks 1 to 8, then every 2 weeks for weeks 9 to 24, and then every 4 weeks starting at week 25.
Tecvayli has boxed warnings for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). Ensure step-up dosing is scheduled and monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment.
Tecvayli has additional warnings for hepatoxicity, infections, neutropenia, hypersensitivity and other administration reactions, and embryo-fetal toxicity. There are no contraindications for Tecvayli.
Opdivo (nivolumab)
On March 20, the FDA approved Opdivo for adult and pediatric patients (aged 12 years and older) with previously untreated stage III or IV classical Hodgkin lymphoma when used in combination with doxorubicin, vinblastine, and dacarbazine (AVD).2
Opdivo is a PD-1 blocking antibody. For adults and paediatric patients weighing 40 kg or more, the recommended dosage is 240 mg delivered intravenously in combination with AVD on days 1 and 15 of each 28-day cycle for up to 6 cycles. For patients weighing less than 40 kg, the recommended dose is 3 mg/kg following the same dosing schedule. Primary G-CSF prophylaxis is recommended starting in cycle 1.
Opdivo has no boxed warning but does have warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplant, and embryo-fetal toxicity. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. There are no contraindications for Opdivo.
Lifyorli (relacorilant)
On March 25, the FDA approved Lifyorli, in combination with nab-paclitaxel, for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 prior treatment regimens, at least 1 of which included bevacizumab.3
Lifyorli is a glucocorticoid receptor antagonist. It has a recommended dose of 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion, until disease progression or unacceptable toxicity.
Lifyorli has no boxed warning but does have warnings for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity. Lifyorli is contraindicated for patients who are receiving concurrent systemic glucocorticoids for lifesaving purposes.
Package inset. Janssen Biotech. 2026. Accessed April 28, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761291s018lbl.pdf
Package Insert. Bristol Myers Squibb Company. 2026. Accessed April 28, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125554s135lbl.pdf
Package insert. Corcept Therapeutics. 2026. Accessed April 28, 2026. https://corcept.com/wp-content/uploads/Lifyorli_PI.pdf February
FDA Roundup: February 2026
In February, the US Food and Drug Administration (FDA) approved 5 treatments for a range of cancers, including pembrolizumab (Keytruda), Optune Pax, acalabrutinib (Calquence), encorafenib (Braftovi), and zongertinib (Hernexeos).
Keytruda (pembrolizumab)
On February 11, the FDA approved Keytruda and Keytruda Qlex in combination with paclitaxel, with or without bevacizumab, for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1, and who have received 1 or 2 prior systemic treatment regimens.1,2
Keytruda is a PD-1-blocking antibody. In this case, Keytruda has a recommended dose of 200 mg every 3 weeks or 400 mg every 6 weeks up to 24 months, or until disease progression or unacceptable toxicity.
Keytruda Qlex is a combination of Keytruda and berahyaluronidase alfa, an endoglycosidase. It has a recommended dose of 395 mg/4800 units every 3 weeks or 790 mg/9600 units every 6 weeks up to 24 months, or until disease progression or unacceptable toxicity.
Keytruda and Keytruda Qlex have no boxed warnings but have warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
There are no contraindications for Keytruda. Keytruda Qlex is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase, or any of its excipients.
Optune Pax
On February 12, the FDA approved Optune Pax, a medical device for the treatment of patients with locally advanced pancreatic cancer.3
Optune Pax is a device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. Optune Pax uses electrically insulated adhesive patches that are placed on the patient’s skin and connected to an electric field generator. The TTFields physically disrupt the rapid cell division that is characteristic of cancer cells, with minimal damage to healthy tissue.
Optune Pax is a continuous treatment that is carried in a specially designed bag; patients should be trained on how to use the device and how to place the patches in the appropriate positions on the body.
Optune Pax is contraindicated in patients with an electronic implant or known sensitivities to the gel used on electrocardiogram stickers or transcutaneous electrical nerve stimulation electrodes.
Calquence (acalabrutinib)
On February 19, the FDA approved Calquence tablets and capsules in combination with Venclexta (venetoclax) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.4
Calquence is a kinase inhibitor and has a recommended dosage of 100 mg taken orally every 12 hours. The recommended regimen with Venclexta is fourteen 28-day cycles of Calquence with the addition of 12 cycles of Venclexta starting at cycle 3. Continue treatment until disease progression, unacceptable toxicity, or the completion of 14 cycles.
Calquence has no boxed warning but does have warnings for serious or opportunistic infections, hemorrhage, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity. There are no contraindications for Calquence.
Braftovi (encorafenib)
On February 24, the FDA granted traditional approval to Braftovi in combination with cetuximab and fluoruracil-based chemotherapy for the treatment of adults with metastatic colorectal cancer with a BRAFV600E mutation.5
Braftovi is a kinase inhibitor. The recommended dose is 300 mg (four 75 mg tablets) orally once daily in combination with cetuximab and mFOLFOX6, or in combination with cetuximab and FOLFIRI, until disease progression or unacceptable toxicity.
Braftovi has no boxed warning but does have warnings for cardiomyopathy, hepatotoxicity, hemorrhage, uveitis, QT prolongation, and embryo-fetal toxicity. Additionally, there are warnings for new primary malignancies (cutaneous and noncutaneous), as well as for tumor promotion in BRAF wild-type tumors. There are no contraindications for Braftovi.
Hernexeos (zongertinib)
On February 26, the FDA granted accelerated approval to Hernexeos for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.6
Hernexeos is a kinase inhibitor. The recommended dose is based on a patient’s body weight. For patients weighing less than 90 kg, the dose is 120 mg orally once a day. For those weighing 90 kg or more, the dose is 180 mg once daily. It may be taken with or without food until disease progression or unacceptable toxicity.
Hernexeos has no boxed warning but does have warnings for hepatoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity. There are no contraindications for Hernexeos.
Package Insert. Merck. 2025. Accessed April 27, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s195lbl.pdf
Package Insert. Merck. 2025. Accessed May 6, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig2.pdf
Package Operational Manual for Physicians. Novocure. 2025. Accessed April 27, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250034C.pdf
Package Insert. AstraZeneca. 2025. Accessed April 27, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210259s012lbl.pdf
Package Insert. Array Biopharma Inc. 2025. Accessed April 27, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf
Package Insert. Boehringer Ingelheim Pharmaceuticals, Inc. 2025. Accessed April 27, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219042s001lbl.pdf January
FDA Roundup: January 2026
In January, the US Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of multiple myeloma.
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
On January 27, the FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.1
Darzalex Faspro is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase. It has a recommended dose of 1800 mg daratumumab and 30,000 units hyaluronidase administered subcutaneously into the abdomen over approximately 3 to 5 minutes.
Darzalex Faspro has no boxed warning, but does have warnings for hypersensitivity and other administration reactions, cardiac toxicity for patients with light chain (AL) amyloidosis, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with cross-matching and red blood cell antibody screening. Darzalex Faspro is contraindicated for patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.
Package Insert. Johnson & Johnson. 2025. Accessed April 22, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s039lbl.pdf