FDA Approves Expansion of Gilead’s HIV Drug in Pediatric Patients

October 25, 2021 - FDA recently approved a new low-dose tablet dosage form of Gilead’s HIV-1 drug, Biktarvy, in pediatric patients.

The agency approved the new dosage for children weighing at least 30 pounds who are virologically suppressed or new to antiretroviral therapy. The approval expands the indication for Biktarvy to include younger children living with HIV-1. 

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, said in the announcement.

“To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The sNDA approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” Parsey continued. 

FDA based its approval of Biktarvy on data from Cohort 3 of a Phase 2/3 open-label, single-arm study. The study found that about 91 percent of participants who switched to Biktarvy remained virologically suppressed at week 24. 

In additional pediatric studies, researchers observed no new adverse reactions or laboratory abnormalities compared to those observed in adults.

Pediatric HIV is a global issue. In 2020, about 850 children worldwide became infected with HIV each day and nearly 330 children died from AIDS-related causes. The spread is mainly due to inadequate access to HIV treatment options. 

FDA first approved Biktarvy 50 milligrams as a once-daily single-tablet regimen to treat HIV-1 infected adults and pediatric patients in 2018. 

In clinical trials through 48 weeks, no patients taking Biktarvy developed treatment-emergent resistance. These results were observed in individuals new to therapy and those who were virologically suppressed and chose to switch regimens.

FDA Approves Tecentriq For Early Non-Small Cell Lung Cancer

FDA recently approved Roche’s Tecentriq as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIA non-small cell lung cancer (NSCLC). 

Tecentriq is currently the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, giving individuals the opportunity to receive immunotherapy and increase their chances of a cure. 

“Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in the announcement. 

FDA based its approval on results from an interim analysis of the Phase 3 IMpower010 study, which found that Tecentriq reduced the risk of disease recurrence or death by 34 percent following platinum-based chemotherapy. 

Safety data for the drug were also consistent with its known and safety profiles. Notably, researchers identified no new safety signals. 

Currently, Tecentriq is approved for six indications in the US, including cancer immunotherapy in front-line treatment of adults with extensive-stage small-cell lung cancer in combination with carboplatin and etoposide. 

The drug is also approved for advanced NSCLC as either a single agent or combined with targeted therapies or chemotherapies.

FDA Approves Merck’s Keytruda For Metastatic Cervical Cancer

FDA recently approved Merck’s Keytruda, combined with chemotherapy, to treat patients with persistent, recurrent, or metastatic cervical cancer whose tumors expressed PD-L1. 

FDA based its approval on the Phase 3 KEYNOTE-826 trial, which found that Keytruda plus chemotherapy, with or without bevacizumab, demonstrated overall and progression-free survival. 

More patients responded to Keytruda plus chemotherapy (68 percent) than chemotherapy with or without bevacizumab (50 percent). The median duration of response was 18 months for Keytruda plus chemotherapy, with or without bevacizumab, and 10.4 months for chemotherapy, with or without bevacizumab. 

Additionally, FDA converted the accelerated approval of Keytruda as a single agent to treat patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1.

This approval provides the first treatment option for women with metastatic cervical cancer in over seven years. 

“Today's news is a meaningful step forward, as it offers a new therapeutic option for these patients and reinforces the role of Keytruda in treating certain types of cervical cancers, with a second indication for the disease,” Roy Baynes, MD, senior vice president, head of global clinical development, and chief medical officer at Merck, said in the announcement.