The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 25 new oncology agents and new indications during the second quarter of 2022. One of the main highlights was the accelerated approval (FDA) of the tumor agnostic dabrafenib + trametinib (Tafinlar® + Mekinist®; Novartis) for treatment of unresectable/metastatic solid tumors with BRAF V600E mutation. This approval is expected to lead to increasingly routine use of BRAF tests in the diagnosis of solid tumors. Also of interest is the approval of trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo; Astra Zeneca) by both agencies for the treatment of unresectable/metastatic HER2-positive breast cancer. Trastuzumab deruxtecan was previously granted accelerated approval by the FDA in December 2019. Another new treatment for early breast cancer was approved by the FDA–olaparib (Lynparza®; Astra Zeneca Pharmaceuticals) for patients with BRCA 1/2 mutations, HER2 negative, high-risk, and previously treated with chemotherapy. This is the first approved medicine targeting BRCA mutations in early breast cancer.
Additional highlights from the second quarter of 2022 include:
- Three chimeric antigen receptor CAR T-cell therapies were approved for treatment of relapsed/refractory lymphoma: axicabtagene ciloleucel (Yescarta®; Kite Pharma) by the EMA for follicular lymphoma and by the FDA for large B-cell lymphoma (LBCL); tisagenlecleucel (Kymriah®; Novartis) FDA accelerated approval for follicular lymphoma; and lisocabtagene maraleucel (Breyanzi®; Juno Therapeutics) by the FDA for large B-cell lymphoma LBCL
- There were several new indications approved for existing therapies:
- Nivolumab + ipilimumab (Opdivo® + Yervoy®; Bristol-Myers Squibb) for first-line treatment esophageal squamous cell carcinoma (FDA)
- “Palliative” was removed from the label for leuprolide acetate (Lupron Depot®; Abbvie Endocrine) (FDA)
- Pembrolizumab (Keytruda®; Merck) received EMA approvals for patients with triple negative breast cancer and melanoma (adolescents aged 12 or older)
- Azacitadine (Vidaza®; Celgene) in juvenile myelomonocytic leukemia (FDA)
- Ivosidenib tablets (Tibsovo®; Servier) in AML
- Selinexor (Nexpovio®; Karyopharm Europe) is now approved by the EMA for use in earlier lines of therapy (second line or later) for multiple myeloma (previously approval was only for patients who received at least 4 prior therapies)
- Two new biologics for neutropenia received approval: pegfilgrastim-PBBK (Fylnetra®; Kashiv Biosciences) approved by the FDA and lipegfilgrastim (Lonquex®; Teva; pediatric indication) by the EMA
- Two bevacizumab biosimilars were approved: Alymsys® (Amneal Pharms) by the FDA and Vegzelma® (Celltrion Healthcare) by the EMA
- There was 1 product indication withdrawn in the US by the manufacturer–the ovarian cancer indication for rucaparib (Rubraca®; Clovis Oncology) after a recent trial failed to show a survival benefit vs chemotherapy for this indication. The other indications were not affected by the withdrawal
The tables below summarize key Q2 oncology approvals:
FDA and EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
axicabtagene ciloleucel |
Yescarta |
Relapsed/refractory LBCL (FDA)
|
CAR T-cell therapy |
Kite Pharma |
4/1/22 |
Fam-trastuzumab deruxtecan-nxki |
Enhertu |
Breast Cancer |
HER2-directed antibody and topoisomerase inhibitor conjugate |
Daiichi Sankyo;
|
5/4/22 (FDA) and 6/27/22 (EMA) |
FDA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Azacitidine |
Vidaza |
Juvenile myelomonocytic leukemia (new indication) |
Nucleoside metabolic inhibitor |
Celgene |
5/20/22 |
Bevacizumab-maly (biosimilar) |
Alymsys |
Colon, lung, glioblastoma, renal cell carcinoma, cervical, ovarian |
VEGF inhibitor |
Amneal Pharms |
4/13/22 |
Dabrafenib + trametinib |
Tafinlar + Mekinist |
Solid tumors with BRAF V600E mutation |
BRAF inhibitor |
Novartis |
6/22/22b |
ipilimumab + nivolumab |
Yervoy + Opdivo |
Esophageal squamous cell carcinoma |
CTLA-4 blocking antibody + anti-PD-1 |
Bristol Myers Squibb |
5/27/22 |
Ivosidenib tablets |
Tibsovo |
AML |
IDH1 inhibitor |
Servier |
5/25/22 |
Leuprolide acetate |
Lupron Depot |
Prostate cancer (“palliative” was removed) |
GnRH agonist |
Abbvie Endocrine |
3/23/22 |
Lisocabtagene maraleucel |
Breyanzi |
Large B-cell lymphoma |
CAR T-cell therapy |
Juno Therapeutics |
6/24/22 |
Nivolumab + fluoropyrimidine- and platinum-based chemotherapy |
Opdivo |
Esophageal squamous cell carcinoma |
PD-1 inhibition |
Bristol Myers Squibb |
5/27/22 |
Pegfilgrastim-pbbk (biologic) |
Fylnetra |
Neutropenia |
Leukocyte growth factor |
Kashiv Biosciences |
5/26/22 |
Tisagenlecleucel |
Kymriah |
Relapsed/refractory follicular lymphoma |
CAR T-cell therapy |
Novartis |
5/27/22b |
EMA Approvals |
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Generic Name |
Brand Name |
Indication |
MOA |
Manufacturer |
Approval |
Asciminib |
Scemblix |
Ph+ CML chronic phase |
Kinase inhibitor |
June 2022 |
|
Atezolizumab |
Tecentriq |
Early-stage NSCLC |
PD-L1 inhibitor |
Roche |
April 2022 |
Bevacizumab (biosimilar) |
Vegzelma |
Colon, rectum, breast, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal, cervix |
Monoclonal antibody |
Celltrion Healthcare Hungary Kft |
June 2022 |
Capmatinib |
Tabrecta |
Advanced NSCLC |
MET inhibitor |
Novartis |
April 2022 |
Dasatinib anhydrous |
Daruph/Anafezyn or Dasatinib Zentiva |
CML and ALL |
TKI |
Zentiva k.s. |
May 22 |
Lipegfilgrastim |
Lonquex |
Neutropenia (pediatric) |
G-CSF |
Teva |
June 2022 |
Melphalan flufenamide (melflufen) |
Pepaxti |
Multiple myeloma |
Inhibits DNA and RNA synthesis |
Oncopeptides AB |
June 2022 |
Mosunetuzumab |
Lunsumio |
Relapsed/refractory follicular lymphoma |
Bispecific monoclonal antibody |
Roche |
June 2022c |
Olaparib |
Lynparza |
Breast cancer |
PARP inhibitor |
Astra Zeneca |
June 2022 |
Pembrolizumab |
Keytruda |
Triple negative breast cancer |
PD-1 inhibitor |
Merck |
April 2022 |
Pembrolizumab |
Keytruda |
Melanoma (adolescents aged 12 and older) |
PD-1 inhibitor |
Merck |
May 2022 |
Selinexor |
Nexpovio |
Multiple myeloma (second line or later) |
Selective inhibitor of nuclear export (SINE) |
Karyopharm Europe |
May 2022 |
Selpercatinib |
Retevmo |
NSCLC (label update, now first -line) |
RET inhibitor |
Eli Lilly |
April 2022 |
ALL, acute lymphocytic leukemia; AML, acute myeloid leukemia; BRAF, B-Raf proto-oncogene serine/threonine kinase; BRCA, breast cancer susceptibility gene; CAR T, chimeric antigen receptor T cells; CML, chronic myeloid leukemia; CTLA-4, cytotoxic T-lymphocyte antigen-4; DNA, deoxyribonucleic acid; EMA, European Medicines Agency; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GnRH, gonadotropin-releasing hormone; HER2, human epidermal growth factor receptor; IDH1, isocitrate dehydrogenase-1; LBCL, large B-cell lymphoma; mAb, monoclonal antibody; MET, mesenchymal-epithelial transition; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; Ph, Philadelphia chromosome; RCC, renal cell carcinoma; RET, rearranged during transfection; RNA, ribonucleic acid; R/R, relapsed/refractory; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.aPlease see each product’s Prescribing Information and Summary of Product Characteristics for full indications and labelling information.bAccelerated approval.cConditional marketing approval.
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