Johnson & Johnson’s bispecific therapy Rybrevant Faspro is now approved for treating head and neck squamous cell carcinoma, a particularly aggressive form of cancer that offers few therapeutic options.
The clearance allows Rybrevant Faspro to be used as a monotherapy for adults whose disease has advanced following chemotherapy or immunotherapy—the current standard regimens. This decision, disclosed after Thursday’s market close, broadens the indication beyond the drug’s prior approvals in non‑small‑cell lung cancer.
Rybrevant is a bispecific antibody that simultaneously inhibits EGFR and MET, receptors frequently over‑expressed in malignancies. Dual inhibition is intended to surmount resistance that often emerges when only one pathway is targeted. The intravenous formulation first received FDA approval in 2021 for EGFR‑mutated non‑small‑cell lung cancer. In 2024, the agency also approved J&J’s oral EGFR inhibitor Lazcluze, and the two agents may be used together to achieve more comprehensive EGFR blockade and further reduce resistance.
Rybrevant Faspro leverages Halozyme’s delivery technology to enable subcutaneous administration of the antibody. The injection can be given in roughly five minutes, a dramatic reduction from the two‑to‑five‑hour infusion required for the IV formulation. The FDA’s December approval for Faspro encompassed all indications then held for the IV version.
“Having redefined outcomes in EGFR+ non‑small‑cell lung cancer, we are unlocking the next chapter of this treatment and bringing meaningful innovation to patients with certain head and neck cancers,” said Yusri Elsayed, J&J’s global therapeutic head, oncology, in the approval announcement.
The accelerated approval is supported by Phase 1b/2 data demonstrating a 42 % overall response rate in head‑and‑neck patients, with 15 % achieving complete responses. Among responders, 56 % sustained their benefit for more than six months.
A pivotal Phase 3 trial is currently underway. It will serve as the confirmatory study for the accelerated designation and may enable a move into the first‑line setting for head‑and‑neck disease. The approval specifically excludes oropharyngeal squamous cell carcinoma driven by human papillomavirus (HPV), a distinct etiology that commonly affects the mouth and throat.
The Rybrevant franchise underpins J&J’s oncology growth strategy. In the first nine months of 2026, worldwide sales of Rybrevant and Lazcluze reached $866 million, reflecting a 67.4 % year‑over‑year increase. J&J has previously projected that Rybrevant could achieve peak sales of roughly $5 billion.
More Cancer Drug Approvals
GSK’s Jempeli (a PD‑1 inhibitor and the company’s flagship cancer product) has been expanded to treat advanced rectal cancer. The agent was originally approved in 2021 for endometrial cancer.
Pfizer’s Tukysa, a small‑molecule HER2 inhibitor, now qualifies for first‑line use in HER2‑positive metastatic breast cancer. The agent was initially cleared in 2020 for second‑line and later settings. Pfizer acquired the drug with its 2023 purchase of Seagen.
Eli Lilly’s pirtobrutinib (Jaypirca), a Bruton tyrosine kinase (BTK) inhibitor, has received FDA approval for first‑line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The agent earned an accelerated approval for third‑line use in 2023, was promoted to second‑line the following year, and has now been converted to a full approval. Jaypirca was originally approved in 2023 for mantle‑cell lymphoma.
Elevar Therapeutics’ lirafugratinib (Lyrfigtu) has been approved for the treatment of advanced cholangiocarcinoma, a rare malignancy of the liver’s bile ducts. The decision is limited to tumors harboring the FGFR2 genetic alteration. Elevar obtained the asset from Relay Therapeutics through a licensing agreement.
Infectious Disease Drug Approvals
Dr. Reddy’s Laboratories has received tentative FDA approval for a generic version of lenacapavir, a long‑acting injectable HIV medication originally developed by Gilead Sciences. Under the President’s Emergency Plan for AIDS Relief (PEPFAR) program, the twice‑year injection will be made available in 120 countries outside the United States. Gilead’s brand Yeztugo was approved by the FDA last year, and the company subsequently granted Dr. Reddy’s a voluntary license for the generic product.
GSK’s Hibsago, an antisense oligonucleotide, has been approved for chronic hepatitis B infection. The agent targets viral messenger RNA, thereby lowering both viral DNA and protein levels. Clinical data indicated that a subset of patients attained a functional cure, defined by the absence of detectable viral markers.
Asahi Kasei’s pritelivir (Hovilpri) has been approved to treat herpes simplex virus lesions in adults who have not responded to three prior standard‑of‑care antivirals. The approval follows the company’s $919 million acquisition of AiCuris Anti‑Infective Cures.
Regulatory Decisions in Neuroscience
AbbVie’s tavapadon (Juvmo), an oral small‑molecule selective partial agonist of D1 and D5 dopamine receptors, has earned FDA approval for Parkinson’s disease. By sparing other dopamine receptors, the agent aims to limit side effects associated with broader dopaminergic stimulation. Juvmo is part of AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics completed in 2024.
Click Therapeutics’ digital therapeutic CT‑155 (Motvista) has obtained FDA clearance for addressing negative symptoms of schizophrenia—including diminished motivation, anhedonia, and social withdrawal. The smartphone‑based adjunctive therapy is intended to complement conventional pharmacotherapy.
Immunology & Inflammation Drug Approvals
Sun Pharma’s Ilumya, an IL‑23 inhibitor antibody, has been expanded to treat active psoriatic arthritis in adults. The agent was initially approved in 2018 for moderate‑to‑severe plaque psoriasis.
AstraZeneca’s Ultomiris, a complement inhibitor, has received accelerated FDA approval for immunoglobulin A nephropathy, a rare kidney‑affecting autoimmune disease. This marks the agent’s fifth approved indication.
Novartis’s Rhapsido, a Bruton tyrosine kinase (BTK) inhibitor, has been further approved for symptomatic dermographism, a chronic hives disorder. The agent was originally cleared last year for second‑line treatment of chronic spontaneous urticaria.
Roche’s Gazyva, a CD20‑targeting antibody, has been labeled for idiopathic nephrotic syndrome, representing its second autoimmune indication in the past year. The agent was previously approved last fall for lupus nephritis and originally received approval for hematologic malignancies.
Regulatory Decisions in Rare Disease
Inovio Pharmaceuticals’ Voceryq, a plasmid DNA‑based immunotherapy, has been approved for recurrent respiratory papillomatosis (RRP). This marks Inovio’s inaugural approved product and represents the second immunotherapy for RRP, after Precigen’s Papzimeos received FDA clearance last year.
Egetis Therapeutics’ tiratricol (Emcitate) has been approved for MCT8 deficiency, a rare inherited disorder characterized by elevated circulating thyroid hormones. This is the first disease‑specific therapy ever cleared for this condition.
Cardiometabolic Drug Approvals
Eli Lilly’s Onswik, a once‑weekly injectable basal insulin for adults with type 2 diabetes, has secured FDA approval. The agent already enjoys regulatory clearances in Europe, Mexico, and Japan. It will compete with Novo Nordisk’s Awiqli, a similarly positioned once‑weekly basal insulin that received FDA approval earlier this year.
Bristol Myers Squibb’s Camzyos, an oral small‑molecule therapy for obstructive hypertrophic cardiomyopathy (HCM), has been expanded to treat pediatric patients weighing ≥30 kg (≈66 lb). The agent was first approved for adults with this condition in 2022.
Regulatory Setbacks
The FDA has placed a partial clinical hold on Bright Minds Biosciences’ Phase 2 trial of BMB‑101, an investigational therapy for seizures associated with developmental and epileptic encephalopathies. The agency’s decision stems from observed toxicity in mouse studies and insufficient pharmacokinetic and juvenile toxicity data to support the planned pediatric enrollment.
Gilead Sciences has disclosed a partial FDA clinical hold on its KITE‑753 program, an autologous CAR‑T cell therapy for relapsed or refractory diffuse large B‑cell lymphoma. The agency’s pause follows the identification of safety discrepancies between Phase 1 and Phase 2 studies, prompting an ongoing investigation.
Photo by Johnson & Johnson
