The FDA approved a the use of a drug combination that represents the first approved therapy in roughly 20 years for patients newly-diagnosed with diffuse large B-cell lymphoma, the non-Hodgkins lymphoma most prevalent in the U.S.

The drug Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) was approved on Wednesday, The combination had been approved in 2019 for use but only for patients who had undergone two prior therapies.

“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” said Dr. Levi Garraway, chief medical officer and head of global product development for Genentech, which manufactures Polivy. “Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”

A study found that roughly 28 months after the combination was administered, a 27% reduction in the risk of disease production or death for patients occurred compared to patients who received standard of care.

“The FDA’s decision gives newly diagnosed patients with this aggressive form of lymphoma their first new treatment option in nearly two decades,” Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society, stated. “One of our major goals at LLS is to support science that moves us toward less toxic, and more effective treatment options, and this drug combination is a step in that direction.”

“While this new drug is a valuable addition for some patients, we need to keep pressing forward to find even better options for DLBCL and every type of blood cancer,” Greenberger added. “But advances like polatuzumab are important, not just for today’s patients, but because science builds on itself, helping us to learn more about effective use of target drugs and harnessing the immune system to help tomorrow’s patients do even better.”

“I believe this gain in progression-free survival is clinically meaningful for patients, and also leads to a reduction in the need for subsequent therapy,” Grzegorz Nowakowski, MD, of the Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota, said.

The Biden administration has authorized the military to prepare for a possible evacuation of the U.S. embassy in Khartoum, Sudan, as rival factions ramp up fighting in the African country.

The Pentagon is moving troops and equipment to a naval base in the small country of Djibouti — around 1,000 miles southeast of Khartoum — to prepare for a rescue mission, according to two Biden administration officials, the Associated Press reported. An American embassy convoy was attacked in the streets of Khartoum earlier this week, and embassy staff remains caught in the middle of a raging conflict that broke out in the country’s capital last week.

“There’s no indication that either side is deliberately going after or trying to hurt or target Americans,” National Security Council spokesman John Kirby said. “But it’s obviously a dangerous situation.”

Over the weekend, hundreds of civilians and paramilitary forces were killed or injured in a series of airstrikes in Khartoum, as the Sudanese army bombed positions held by a rival military force in a power struggle that some international observers fear could ignite a full-blown civil war.

Deputy State Department spokesman Vedant Patel confirmed Thursday that all American embassy personnel were safe, but said that under the current conditions, it is not safe to attempt an evacuation, the AP reported. There are around 70 Americans at the embassy in Sudan’s capital. There are also an estimated 16,000 private U.S. citizens currently in the country, but the State Department said that number is likely inaccurate since it only includes Americans who registered with the embassy.

Thousands of people have already fled the capital city, and Japan and Tanzania have also said they are working on getting their embassy personnel out of Sudan. The Sudanese military and the paramilitary Rapid Support Forces agreed to a humanitarian ceasefire on Tuesday, but the agreement failed as fighting broke out within minutes of the supposed agreement, according to the BBC. Another ceasefire was agreed upon on Wednesday, but gunfire could still be heard throughout the city.

Mohammed Alamin, a journalist based in Khartoum, told the BBC, “It’s really horrible — these warring parties are firing randomly everywhere. I saw, myself, hundreds of people going outside Khartoum, rushing to travel to the neighboring states.”

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The Biden administration’s preparation to evacuate Americans from Sudan comes less than two years after its botched attempt to evacuate Americans and U.S. allies from Afghanistan. During the U.S. withdrawal from Kabul in August 2021, 13 U.S. service members and over 100 Afghans were killed when a member of the Taliban detonated an explosive at the Kabul airport.

Michael Whittaker contributed to this report.