FDA Approves Kanjinti for HER2 Cancers

The FDA has approved Kanjinti (trastuzumab-anns), Amgen’s biosimilar to Genentech’s Herceptin, for treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in adult patients. 

Kanjinti is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of Kanjinti is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab.

Kanjinti is indicated as the first-line of treatment for HER2 overexpressing breast cancer, in combination with paclitaxel. The drug can also be used as a single agent for the treatment of HER2 overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. 

"The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer," said David M. Reese, MD, executive vice president of Research and Development at Amgen. "KANJINTI is the third biosimilar from our portfolio to receive FDA approval, highlighting our long-term commitment to providing patients with serious illnesses access to high-quality biological therapies."

For the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, Kanjinti is to be used in conjunction with cisplatin and capecitabine or 5-fluorouracil for patients who have not received prior treatment for metastatic disease. 

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Kanjinti will be available as 420 mg of lyophilized powder in a multiple-dose vial to be reconstituted. 

Prescribing information warns that the drug should not be administered as an intravenous push or bolus, should not be mixed with other drugs, and should not be substituted for or with ado-trastuzumab emtansine. 

Trastuzumab-anns does not carry any contraindications, but does come with a warning for the potential of exacerbated chemotherapy-induced neutropenia.

For treatment of adjuvant breast cancer:

• During and following paclitaxel, docetaxel, or ceteaxel and carboplatin

• Initial dose: 4 mg/kg IV over 90 mins, followed by 2 mg/kg over 30 minutes weekly during chemotherapy for the first 12 weeks with paclitaxel or docetaxel, or for the first 18 weeks when used with docetaxel and carboplatin. 

• Single agent within three weeks following completion of multimodality anthracylcin-based chemotherapy regimens

• 8 mg initial IV over 90 minutes, followed by 6 mg/kg IV over 30 to 90 minutes every three weeks. Subsequent treatment should not last beyond one year. 

For treatment of metastatic breast cancer:

• 4 mg/kg initial IV over 90 mins, followed by 2 mg/kg over 30-90 minutes every three weeks until disease progression

• To be used with or without paclitaxel 

For treatment of metastatic breast cancer:

• 8 mg/kg initial IV over 90 minutes, followed by 6 mg/kg over 30 to 90 minutes every three weeks until disease progression

Most common adverse events reported with use of Kanjinti include headache, diarrhea, nausea, chills, infection, congestive heart failure, insomnia, cough, rash, neutropenia, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. Not all adverse events are equal across disease states. 

Full Kanjinti Prescribing Information