Breast cancer patients will now have access to Swiss drugmaker Roche’s Phesgo, a first-of-its-kind fixed-dose injectable drug that combines two monoclonal antibodies. Keeping an eye on concerns over its high price, company officials said, they were looking at ways to make the drug available for those who need it.

The injectable drug combines breast cancer drugs Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, to treat early and metastatic HER2-positive breast cancer, a more aggressive form of the cancer. The drug is given sub-cutaneously or under the skin, with intravenous chemotherapy.

V Simpson Emmanuel, Roche Pharma (India) Chief Executive and Managing Director, said the innovative drug would cut short the time to administer the combination drug from about eight hours to 20 minutes. Besides patient convenience, this would also free up healthcare infrastructure, he said, especially since cancer care systems were inadequate in the country. This aggressive form of cancer accounted for about 20 per cent of breast cancers.

Imported from Switzerland, the drug is priced at about ₹2.75 lakh, similar to Roche’s Perjeta, a company representative told BusinessLine. Responding to whether it would be covered by health insurance, an official said, IRDAI had included several modern treatment methods for insurance coverage. Roche was talking to insurers for Phesgo as well, he said, adding that they were also talking to Central and State governments, that presently covered the individual breast cancer drugs Herceptin and Perjeta. This, along with Roche’s Patient Assistance Program would help significantly drive access, officials said.

Phesgo was first approved by the United States Food and Drug Administration in June 2020 during the peak of the Covid pandemic, and by the European Medicines Agency (EMA) in December 2020. In India, it was approved by the Drugs Controller General of India in October 2021 and the import licence was granted in January 2022. Globally, over 17,000 breast cancer patients have benefited from Phesgo as on December 2021, the company said.

Trials and caution

No Indian patients had participated in trials on this drug, said Bruno  Jolain, Medical Director, Roche Pharma, adding that the company would undertake post marketing surveillance. He indicated to local participation in forthcoming trials.

While approving the drug, the FDA had said, its decision was based “on the results of a non-inferiority study in patients with HER2-positive early breast cancer, which demonstrated Phesgo had comparable efficacy and safety as IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with Phesgo due to the subcutaneous route of administration.”

Further, the FDA cautioned, “Prescribing information for Phesgo includes a boxed warning to advise health care professionals and patients about the risk of potential heart failure, fetal harm and lung toxicity. Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab.”

On this concern, a Roche representative said, “The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity.”

On side-effects, the FDA said, the most common ones were were alopecia (hair loss), nausea, diarrhea, anemia (reduced number of red blood cells) and asthenia (lack of energy). Phesgo can cause worsening of chemotherapy induced neutropenia (low level of white blood cells), it added.